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

Vertex Pharmaceuticals

Status and phase

Enrolling

Phase 1

Conditions

Pain

Treatments

Drug: Placebo

Drug: VX-993

Study type

Interventional

Funder types

Industry

Identifiers

NCT06394167

VX23-993-002

Details and patient eligibility

About

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.

Full 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.).

Enrollment

110 estimated patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Key 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

Key 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

Other protocol defined Inclusion/Exclusion criteria may apply.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

Quadruple Blind

110 participants in 4 patient groups, including a placebo group

Part A: Single Ascending Dose (SAD)

Experimental group

Description:

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

Treatment:

Drug: VX-993

Part B: Multiple Ascending Dose (MAD)

Experimental group

Description:

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.

Treatment:

Drug: VX-993

Placebo Part A

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo

Placebo Part B

Placebo Comparator group

Description:

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