A Phase 1 Dose Escalation Study of Intravenous VX-993 in Healthy Adults

NCT ID: NCT06394167

Last Updated: 2025-03-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-09
• Study Completion Date: 2025-02-18

Brief Summary

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of intravenously administered VX-993 at different doses in healthy participants.

Detailed Description

This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Part A: Single Ascending Dose (SAD)

Participants will be randomized to receive a single dose of different dose levels of VX-993.

Group Type: EXPERIMENTAL

VX-993

Intervention Type: DRUG

Solution for IV administration.

Part B: Multiple Ascending Dose (MAD)

Participants will be randomized to receive multiple doses of different dose levels of VX-993. The dose levels will be determined based on the data from Part A.

Group Type: EXPERIMENTAL

VX-993

Intervention Type: DRUG

Solution for IV administration.

Placebo Part A

Participants will be randomized to receive placebo matched to VX-993.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Solution for IV administration.

Placebo Part B

Participants will be randomized to receive multiple doses of placebo matched to VX-993.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Solution for IV administration.

Interventions

VX-993

Solution for IV administration.

Intervention Type: DRUG

Placebo

Solution for IV administration.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Body mass index (BMI) of 18.0 to 32.0 kilogram per meter square (kg/m^2), inclusive
• A total body weight of more than (>) 50 kg
• Nonsmoker or ex-smoker for at least 3 months before first dose of the study drug

Exclusion Criteria

• History of febrile illness or other acute illness that has not fully resolved within 14 days before the first dose of study drug.
• Any condition possibly affecting drug distribution, metabolism, or excretion

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Vertex Pharmaceuticals Incorporated

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

ICON Lenexa

Lenexa, Kansas, United States

Countries

United States

Other Identifiers

VX23-993-002

Identifier Type: -

Identifier Source: org_study_id