ANG-3070 in Healthy Adult Participants

Study Purpose

This is a Phase 1 study, to assess the safety, tolerability, pharmacokinetics, and food effect of single and multiple ascending doses of ANG-3070 in healthy adult participants. This study is comprised of 10 cohorts. 6 single ascending dose (SAD) cohorts and 4 multiple ascending dose (MAD) cohorts. Each cohort will have a total of 8 subjects: SAD and MAD (2 subjects receiving placebo and 6 subjects receiving active ANG 3070)

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 - 65 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Healthy male or female volunteers, aged 18 to 65 years (inclusive at the time of informed consent); 2. Participants must be in good general health, with no significant medical history, have no clinically significant abnormalities on physical examination at Screening and/or before administration of the initial dose of study drug; 3. Participants must have a minimum body weight of 50 kg and a Body Mass Index (BMI) between ≥18.0 and ≤32.0 kg/m2 at Screening;

Exclusion Criteria:

1. Pregnant or lactating at Screening or planning to become pregnant (self or partner) at any time during the study, including the follow-up period; 2. Prior or ongoing medical conditions, medical history, physical findings, or laboratory abnormality that, in the Investigator's (or delegate's) opinion, could adversely affect the safety of the participant; 3. History of gastrointestinal (GI) disorders such as celiac disease, atrophic gastritis, lactose intolerance, and Helicobacter (H.) pylori infection; 4. Presence of any underlying physical or psychological medical condition that, in the opinion of the Investigator, would make it unlikely that the participant will comply with the protocol or complete the study per protocol; 5. Any surgical or medical condition that could interfere with the absorption, distribution, metabolism, or excretion of the study drug; 6

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.

NCT04196179
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.

Angion Biomedica Corp
Principal Investigator

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

Shakil Aslam, MD
Principal Investigator Affiliation Angion Biomedica
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

This is a Phase 1 study, to assess the safety, tolerability, pharmacokinetics, and food effect of single and multiple ascending doses of ANG-3070 in healthy adult participants. Each cohort will have a total of 8 subjects: SAD and MAD (2 subjects receiving placebo and 6 subjects receiving active ANG 3070). The study design employs sentinel dosing with 2 subjects (1 placebo, 1 active treatment) at least 24 hours prior to remainder of cohort for dose cohort 1. SAD cohorts are defined as follows, with the FE crossover occurring for participants in cohort A3 on Day 15. A1 ANG-3070 50 mg (n=6) / Placebo (n=2) A2 ANG-3070 100 mg (n=6) / Placebo (n=2) A3 ANG-3070 200 mg (n=6) / Placebo (n=2) A3 Day 15** ANG-3070 200mg (n=6) / Placebo (n=2) A4 ANG-3070 400 mg (n=6) / Placebo (n=2) A5 Day 1 ANG-3070 800 mg (n=6) / Placebo (n=2) A6 Day 1 ANG-3070 1200 mg (n=6) / Placebo (n=2) MAD cohorts will receive drug or placebo twice daily for 7 consecutive days (Day 1 to Day 7) , or once daily for 14 (Day 1 to Day 14) are defined as follows: B1 ANG-3070 50 mg (n=6) / Placebo (n=2) B2 ANG-3070 100 mg (n=6) / Placebo (n=2) B3 ANG-3070 250 mg (n=6) / Placebo (n=2)

Arms & Interventions

Arms

Experimental: SAD

A1 Day 1 ANG-3070 50 mg (n=6) / Placebo (n=2) Oral A2 Day 1 ANG-3070 100 mg (n=6) / Placebo (n=2) Oral A3 Day 1 ANG-3070 200 mg (n=6) / Placebo (n=2) Oral Day 15** ANG-3070 200mg (n=6) / Placebo (n=2) Oral A4 Day 1 ANG-3070 400 mg (n=6) / Placebo (n=2) Oral A5 Day 1 ANG-3070 800 mg (n=6) / Placebo (n=2) Oral A6 Day 1 ANG-3070 1200 mg (n=6) / Placebo (n=2) Oral

Experimental: MAD

B1 ANG-3070 50 mg (n=6) / Placebo (n=2) B2 ANG-3070 100 mg (n=6) / Placebo (n=2) B3 ANG-3070 250 mg (n=6) / Placebo (n=2)

Interventions

Drug: - ANG3070

ANG-3070 drug product is a an immediate release oral solid. The drug product consists of a Size 00 Swedish orange capsule containing drug substance (10 mg, 50 mg, or 250 mg) with no excipients.

Drug: - Placebo oral capsule

ANG-3070 placebo capsules visually match the drug product.

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

Nucleus Network, VIC, Melbourne, Australia

Status

Recruiting

Address

Nucleus Network, VIC

Melbourne, , 3004

Terms of Service

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