ANG-3070 in Healthy Adult Participants

NCT04196179 | Completed Phase 1 FDA Drug

• 1 other identifier: ANG-3070-001
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 1

Brief Summary

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 12 cohorts. 5 single ascending dose (SAD) cohorts 6multiple ascending dose (MAD) cohorts, and 1 single dose food effect (FE) cross-over cohort Each cohort will have a total of 8 subjects: SAD and MAD (2 subjects receiving placebo and 6 subjects receiving active ANG-3070)

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (5)

• Difference in Adverse Events

  Difference versus placebo in the number of subjects with adverse events to evaluate safety and tolerability of ANG3070.

  Up to the Follow Up visit 8 days after the last study drug administration

• Difference in Vital Signs

  Difference versus placebo in the number of subjects with abnormal vital signs to evaluate safety and tolerability of ANG3070.

  Up to the Follow Up visit 8 days after the last study drug administration

• Difference in Physical Exam

  Difference versus placebo in the number of subjects with abnormal Physical examination to evaluate safety and tolerability of ANG3070

  Up to the Follow Up visit 8 days after the last study drug administration

• Difference in Lab Values

  Difference versus placebo in the number of subjects with abnormal lab values to evaluate safety and tolerability of ANG3070.

  Up to the Follow Up visit 8 days after the last study drug administration

• Difference in ECG QT interval

  Difference versus placebo in the number of subjects with abnormal ECG QT interval to evaluate safety and tolerability of ANG3070

  Up to the Follow Up visit 8 days after the last study drug administration

Secondary Outcomes (1)

• Assess PK

  Up to the Follow Up visit 8 days after the last study drug administration

Study Arms (2)

SAD

EXPERIMENTAL

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 600 mg (n=6) / Placebo (n=2) Oral D1 Single Dose Food Effect: Day 1 ANG 3070 600 mg \*with and without food\* (n=6)/ Placebo (n=2) Oral

Drug: ANG3070; Drug: Placebo oral capsule

MAD

EXPERIMENTAL

B1 ANG-3070 50 mg BID (n=6) / Placebo (n=2) B2 ANG-3070 100 mg BID (n=6) / Placebo (n=2) B3 ANG-3070 250 mg BID (n=6) / Placebo (n=2) B4 ANG-3070 500 mg, BID (n=6)/ Placebo (n=2) C1 ANG-3070 400 mg, QD(n=6)/ Placebo (n=2) C2 ANG-3070 600 mg, QD (n=6)/ Placebo (n=2)

Drug: ANG3070; Drug: Placebo oral capsule

Interventions

ANG3070 DRUG

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.

MAD; SAD

Placebo oral capsule DRUG

ANG-3070 placebo capsules visually match the drug product.

MAD; SAD

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy male or female volunteers, aged 18 to 65 years (inclusive at the time of informed consent);
• 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; and
• 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;

You may not qualify if:

• Pregnant or lactating at Screening or planning to become pregnant (self or partner) at any time during the study, including the follow-up period;
• 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;
• History of gastrointestinal (GI) disorders such as celiac disease, atrophic gastritis, lactose intolerance, and Helicobacter (H.) pylori infection;
• 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;
• Any surgical or medical condition that could interfere with the absorption, distribution, metabolism, or excretion of the study drug;

Sponsors & Collaborators

• Angion Biomedica Corp: lead

Study Sites (1)

Nucleus Network, VIC

Melbourne, 3004, Australia

Location

Study Officials

• Shakil Aslam, MD

  Angion Biomedica

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2019
• First Posted: December 12, 2019
• Study Start: December 17, 2019
• Primary Completion: November 27, 2020
• Study Completion: March 10, 2021
• Last Updated: July 21, 2021

Record last verified: 2021-07

Locations

AU (1)