SAD Study to Assess the Safety, Tolerability, PK, and In-Vivo Performance of AMT-126 in Healthy Male and Female Subjects

Applied Molecular Transport

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Placebo; Drug: AMT-126; Other: Radioactive Tablet (Part 2 Only)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05476107

AMT-126-001

2020-005779-11 (EudraCT Number)

Details and patient eligibility

About

Phase 1 Study of the Safety, Tolerability and Pharmacokinetics of Single Ascending Doses of AMT-126 and Optional Pharmacoscintigraphic Assessment of Oral AMT-126

Full description

A Phase 1 Study in up to 2 Parts, to Assess the Safety, Tolerability, and Pharmacokinetics of Single Ascending Oral Doses of AMT-126 in the Fasted State (in Part 1) and to Evaluate the In Vivo Performance of an AMT-126 Oral Tablet Through Pharmacoscintigraphic Assessment in the Fed and Fasted State (in Optional Part 2) in Healthy Male and Female Subjects

Enrollment: 50 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

PART 1 & 2 (Healthy Volunteers)

Inclusion Criteria:

• Healthy male subjects and female subjects of NOCBP.
• Between 18 and 55 years of age (Part 1) and 30 and 55 years of age (Part 2), inclusive.
• A body mass index of between 18.0 and 32.0 kg/m2, inclusive.
• Contraception requirements for male & female subjects.

Exclusion Criteria:

• Known hypersensitivity or allergy to AMT-126 or excipient contained in the drug formulation.
• Clinically significant abnormalities in laboratory test results (including complete blood count, chemistry panel including kidney panel, and urinalysis).
• Presence, or history of clinically significant disease which requires treatment, as judged by the investigator.
• Evidence of current SARS-CoV-2 or COVID infection.
• Women of child-bearing potential.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

---

50 participants in 3 patient groups, including a placebo group

AMT-126

Experimental group

Description:

oral AMT-126

Treatment:

Drug: AMT-126

Placebo

Placebo Comparator group

Description:

oral placebo

Treatment:

Drug: Placebo

Radioactive Tablet (Part 2 only)

Other group

Description:

oral radioactive tablet for scintigraphic analysis

Treatment:

Other: Radioactive Tablet (Part 2 Only)