Clinical trial NCT04196179: ANG-3070 in Healthy Adult Participants
Official title: A Phase 1, Randomized, Double-Blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Determine the Safety, Tolerability, Pharmacokinetics, and Food Effect of ANG-3070 in Healthy Adult Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Angion Biomedica Corp
Sponsor class: INDUSTRY
First posted: 2019-12-12
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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)

Detailed description: 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 and in cohort D1 on Day 5:

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 15ANG-3070 200mg (n=6) / Placebo (n=2) A4 ANG-3070 400 mg (n=6) / Placebo (n=2) A5 Day 1 ANG-3070 600 mg (n=6) / Placebo (n=2) D1 Day 1 ANG-3070 600 mg Single Dose (n=6) / Placebo (n=2) D1 Day 5 (ANG-3070 600 mg Single Dose (n=6) / Placebo (n=2)

MAD cohorts will receive drug or placebo twice daily for 14 consecutive days (Day 1 to Day 14) or drug or placebo once daily for 14 consecutive days (Day 1 to Day 14) as follows:

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)

Eligibility 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; and
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;

Primary outcomes:
measure: Difference in Adverse Events
timeFrame: Up to the Follow Up visit 8 days after the last study drug administration
measure: Difference in Vital Signs
timeFrame: Up to the Follow Up visit 8 days after the last study drug administration
measure: Difference in Physical Exam
timeFrame: Up to the Follow Up visit 8 days after the last study drug administration
measure: Difference in Lab Values
timeFrame: Up to the Follow Up visit 8 days after the last study drug administration
measure: Difference in ECG QT interval
timeFrame: Up to the Follow Up visit 8 days after the last study drug administration
Secondary outcomes:
measure: Assess PK
timeFrame: Up to the Follow Up visit 8 days after the last study drug administration
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Nucleus Network, VIC
Study officials:
affiliation: Angion Biomedica
name: Shakil Aslam, MD
role: STUDY_DIRECTOR
References: