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A First in Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of PMG1015

Study Purpose

This is a Phase 1A, first in human, randomized, double-blinded, placebo-controlled, dose escalation study of PMG1015 in healthy adult volunteers. PMG1015 is a monoclonal antibody, being developed as a novel therapeutic treatment for patients with Idiopathic Pulmonary fibrosis (IPF). This study aims to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of PMG1015 after Single ascending doses (SAD).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 60 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Healthy male or non-pregnant, non-lactating female volunteers, between 18 and 60 years of age, inclusive at the time of informed consent. 2. Body mass index (BMI) between 17.5 and 32.0 kg/m2 (inclusive) and body weight between 50 and 100 kg for males and between 45 and 100 kg for females. 3. No clinically significant clinical laboratory values (Hematology, coagulation, biochemistry and urinalysis) at the discretion of the PI. 4. Females of child bearing potential must use an acceptable, highly effective double contraception and have a negative pregnancy test at Screening and Day-1. 5. Documented evidence of surgical sterilization at least 6 months prior to screening for women or vasectomy at least 90 days prior to screening. 6. Women not of child bearing potential must be menopausal for >/= 12 months. 7. Males must not donate sperms for at least 90 days after PMG1015 administration.

Exclusion Criteria:

1. History or evidence of clinically significant condition, including but not limited to any cardiovascular, gastrointestinal, endocrinologic, hematologic, psychiatric, renal disease, musculoskeletal, infectious, or neurological condition or any chronic medical condition and/or other major disease, as determined by the PI. 2. A PR < 40 or > 100 beats per minute, mean systolic blood pressure (SBP) > 140 mmHg, or mean diastolic blood pressure (DBP) > 95 mmHg . 3. A mean corrected QT interval using Fridericia's formula (QTcF) interval at Screening > 450 ms in males and > 470 ms in females. If the mean QTcF exceeds these limits, one additional triplicate ECG will be performed. 4. Any clinically significant abnormalities in rhythm, conduction, or morphology of the resting ECG and any abnormalities in the 12-lead ECG that, in the judgment of the PI, may interfere with the interpretation of QTc-interval changes, including abnormal ST-T wave morphology or left ventricular hypertrophy. 5. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or creatinine > 1.5 × the upper limit of the normal range (ULN) or total bilirubin or lymphocyte counts > ULN. 6. Participants with a positive toxicology screening panel or alcohol breath test on Screening/Day-1. 7. Participants with a history of substance abuse or dependency or history of recreational IV drug use over the last 2 years. 8. Plasma donation/Blood donation or significant blood loss within 60 days prior to the first IP administration. 9. Use of any IP (including other investigational mAb products) or investigational medical device within 30 days prior to Screening or 5 half-lives of the product (whichever is the longest) or participation in more than 4 investigational drug studies within 1 year prior to screening. 10. Major surgery (general anesthetic) within 3 months or minor surgery (local anesthetic) within 1 month prior to IP administration, or planned surgery during the study period, which is determined by the PI to be clinically relevant. 11. Fever or symptomatic bacterial or viral infection. 12. Participants who have received live vaccines or attenuated vaccines within 1 month before dosing. 13. Participants with any active malignancy or history of malignancy within 5 years prior to enrolment. 14. Use of any other prescription medications. 15. History of anaphylaxis, allergic reactions to the excipients of IP, asthma. 16. Positive blood screen for HIV1/2 antibody, Hepatitis B surface antigen, hepatitis C virus, or syphilis at screening. 17. Participants with an inability to tolerate venous access. 18. Pregnant or lactating at Screening or planning to become pregnant (self or partner) at any time during the study, including the follow-up period. 19. An employee of Pulmongene or Novotech (Australia) Pty Ltd. 20. Participant is unwilling to abstain from alcohol beginning 48 hours prior to admission to the CRU and while resident at the CRU. 21. Any other condition or finding that in the opinion of the PI or designee would put the participant or study conduct at risk.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05022771
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Pulmongene Ltd.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Richard Friend
Principal Investigator Affiliation Nucleus Network
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Australia
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Idiopathic Pulmonary Fibrosis
Additional Details

Participants will be enrolled and randomized into 1 of 6 cohorts in a double-blind manner.

Arms & Interventions

Arms

Experimental: Single Ascending Doses Cohort 1a

Subjects will receive either Dose level 1 of PMG1015 or Placebo

Experimental: Single Ascending Doses Cohort 1b

Subjects will receive either Dose level 2 of PMG1015 or Placebo

Experimental: Single Ascending Doses Cohort 1c

Subjects will receive either Dose level 3 of PMG1015 or Placebo

Experimental: Single Ascending Doses Cohort 1d

Subjects will receive either Dose level 4 of PMG1015 or Placebo

Experimental: Single Ascending Doses Cohort 1e

Subjects will receive either Dose level 5 of PMG1015 or Placebo

Experimental: Single Ascending Doses Cohort 1f

Subjects will receive either Dose level 6 of PMG1015 or Placebo

Interventions

Drug: - PMG1015 Dose 1

Dose level 1 of PMG1015

Drug: - PMG1015 Dose 2

Dose level 2 of PMG1015

Drug: - PMG1015 Dose 3

Dose level 3 of PMG1015

Drug: - PMG1015 Dose 4

Dose level 4 of PMG1015

Drug: - PMG1015 Dose 5

Dose level 5 of PMG1015

Drug: - PMG1015 Dose 6

Dose level 6 of PMG1015

Drug: - Placebo

Placebo to match

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Herston, Queensland, Australia

Status

Recruiting

Address

Q-Pharm Pty Ltd, Clive Berghofer Cancer Research Centre

Herston, Queensland, 4006

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