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A First in Human, Dose Escalation Study to Evaluate the Safety and Tolerability of BBP-671 in Healthy Volunteers and Patients With Propionic Acidemia or Methylmalonic Acidemia

NCT04836494 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 79

Last updated 2023-12-21

No results posted yet for this study

Summary

The purpose of this study is to assess the safety, tolerability, PK and PD of BBP-671 in healthy volunteers and patients with Propionic Acidemia or Methylmalonic Acidemia.

Conditions

Interventions

DRUG

BBP-671

BBP-671, oral suspension

DRUG

Placebo

Placebo matching BBP-671

DRUG

BBP-671

BBP-671, tablet

Sponsors & Collaborators

  • CoA Therapeutics, Inc., a BridgeBio company

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · VP Clinical Development, CoA Therapeutics, Inc., a Bridgebio company

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
15 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-03-25
Primary Completion
2023-11-20
Completion
2023-11-20
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04836494 on ClinicalTrials.gov