ANG-3070 in Healthy Adult Participants

Study Overview
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Brief Summary
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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
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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)

Official Title
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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

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Drug: ANG3070
* Drug: Placebo oral capsule


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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; Exclusion Criteria: 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;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SAD<br>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<br>* 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.<br>Drug: Placebo oral capsule<br>* ANG-3070 placebo capsules visually match the drug product.<br>|
| Experimental: MAD<br>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<br>* 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.<br>Drug: Placebo oral capsule<br>* ANG-3070 placebo capsules visually match the drug product.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess PK | To assess the pharmacokinetics (PK) of single and multiple ascending doses of ANG-3070 and to evaluate the effect of a high fat meal on the PK of a single dose of ANG-3070 administered to healthy adult participants | Up to the Follow Up visit 8 days after the last study drug administration |