A Phase I Study of Single and Multiple Doses of VG290131 in Healthy Subjects

A Randomized, Double-Blind, Placebo-Controlled Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of Orally Administered VG290131 in Healthy Adult Subjects

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06081465

Enrollment

Registered

2023-10-13

Start date

2023-10-20

Completion date

2024-12-31

Last updated

2024-07-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Brief summary

This is a randomized, double-blind, placebo-controlled phase I study to evaluate the safety, tolerability and PK profiles of orally administered VG290131 in healthy subjects. The main questions it aims to answer are: 1. The safety and tolerability of VG290131 when administered orally as a single dose and multiple doses in healthy subjects. 2. The pharmacokinetic (PK) profiles of VG290131 and the food effect on the PK profiles of VG290131 in healthy subjects. Approximately 86 subjects will be enrolled in the study.

Interventions

DRUGVG290131

The study drug and matching placebo will be administered orally.

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

OTHER

Masking

DOUBLE (Subject, Investigator)

Masking description

Eligible subjects will be sequentially enrolled cohort by cohort. In each cohort, subjects will be randomized to receive VG290131 or matching placebo, respectively.

Intervention model description

The study consists of three parts: a single ascending dose (SAD) part, a multiple ascending dose (MAD) part and a food effect (FE) part. The FE study is incorporated as part of the SAD study. Approximately 86 subjects will be enrolled in the study. SAD+FE study: 6 cohorts (1, 5, 25, 50, 100, and 200 mg), 8 subjects in each cohort, except that there are 14 subjects in the 5 mg cohort, which is the FE study cohort. MAD study: 4 cohorts (1, 5, 25, and 100 mg), 8 subjects in each cohort.

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

A subject will be eligible for inclusion in this study only if all of the following criteria are met: 1. Willing to comply with protocol required visit schedule and visit requirements and provide written ICF; 2. Healthy adult male and female subjects, aged 18 to 45 years of age (inclusive) at the time of signing the ICF; 3. Body mass index between 18.0 and 32.0 kg/m2, inclusive; 4. Considered medically healthy as determined by the investigator, based on medical history and clinical evaluations including physical examination, clinical laboratory tests, vital sign measurements, and 12-Lead ECG; 5. Male subjects must agree to practice true abstinence; be surgically sterilized (performed at least 6 months prior to screening and documented to no longer produce sperm - verbal confirmation through medical history review acceptable); or agree to use a condom plus effective contraception methods for their female partner, if of childbearing potential, from the signing of ICF to 3 months after the last dose of IMPs and refrain from donating sperm during this period. These contraception requirements do not apply if the male subject is in an exclusively same sex relationship; 6. Female subjects are eligible to participate if they are not pregnant, not breastfeeding, and at least 1 of the following conditions applies: * Women of non-childbearing potential (WONCBP), defined as surgically sterile (hysterectomy, bilateral salpingectomy, bilateral tubal ligation or bilateral oophorectomy - verbal confirmation through medical history review acceptable) or postmenopausal (no menses for 12 months and confirmed by follicle stimulating hormone \[FSH\] level ≥40 mlU/mL); * WOCBP and agree to practice true abstinence or agrees to use a highly effective method of contraceptions consistently from the signing of ICF to 3 months after the last dose of investigational medicinal products \[IMPs\] and refrain from donating eggs during this period. And WOCBP must have a negative serum and/or urine pregnancy test result within 7 days prior to the first dose of IMPs. * Subject is in an exclusively same-sex relationship.

Exclusion criteria

A subject meeting any of the following

Design outcomes

Primary

Measure	Time frame	Description
To evaluate the safety and tolerability of VG290131 by TEAEs	From admission to discharge, up to 12 days.	To evaluate the safety and tolerability of VG290131 after SAD and MAD doses to healthy volunteers by assessing the incidence, severity, and causality of treatment-emergent adverse events (TEAEs).
To evaluate the safety and tolerability of VG290131 by 12-Lead ECG	From admission to discharge, up to 12 days.	To evaluate the safety and tolerability of VG290131 after SAD and MAD doses to healthy volunteers by assessing the number and percentage of subjects with clinically significant changes in 12-Lead ECG (RR, PR, QRSD, QT, and QTc).
To evaluate the safety and tolerability of VG290131 by vital signs	From admission to discharge, up to 12 days.	To evaluate the safety and tolerability of VG290131 after SAD and MAD doses to healthy volunteers by assessing the number and percentage of subjects with clinically significant changes in vital signs (Blood pressure, heart rate, body temperature, and respiration rate).
To evaluate the safety and tolerability of VG290131 by physical examinations	From admission to discharge, up to 12 days.	To evaluate the safety and tolerability of VG290131 after SAD and MAD doses to healthy volunteers by assessing the number and percentage of subjects with clinically significant changes in physical examinations (Skin and mucosa, lymph nodes, head, eyes, ears, nose, and throat (HEENT), chest, abdomen, spine and limbs, musculoskeletal system, and nervous system).
To evaluate the safety and tolerability of VG290131 by clinical laboratory tests	From admission to discharge, up to 12 days.	To evaluate the safety and tolerability of VG290131 after SAD and MAD doses to healthy volunteers by assessing the number and percentage of subjects with clinically significant changes in clinical laboratory tests (hematology, coagulation, biochemistry and urine analysis).

Secondary

Measure	Time frame	Description
To evaluate PK parameter CL/F of VG290131 after a single dose	From admission to discharge, up to 12 days.	CL/F of VG290131 under fasted and fed conditions will be calculated after a single dose.
To evaluate PK parameter Vz/F of VG290131 after a single dose	From admission to discharge, up to 12 days.	Vz/F of VG290131 under fasted and fed conditions will be calculated after a single dose.
To evaluate PK parameter MRT of VG290131 after a single dose	From admission to discharge, up to 12 days.	MRT of VG290131 under fasted and fed conditions will be calculated after a single dose.
To evaluate PK parameter λz of VG290131 after a single dose	From admission to discharge, up to 12 days.	λz of VG290131 under fasted and fed conditions will be calculated after a single dose.
To evaluate PK parameter Cmax of VG290131 after a single dose	From admission to discharge, up to 12 days.	Cmax of VG290131 under fasted and fed conditions will be calculated after a single dose.
To evaluate PK parameter Cmin,ss of VG290131 after multiple doses	From admission to discharge, up to 12 days.	The minimum observed concentration at steady state (Cmin,ss) of VG290131 will be calculated after multiple doses from Day 1 to Day 7.
To evaluate PK parameter Cav,ss of VG290131 after multiple doses	From admission to discharge, up to 12 days.	The average concentration during a dosing interval at steady state (Cav,ss) of VG290131 will be calculated after multiple doses from Day 1 to Day 7.
To evaluate PK parameter AUCss of VG290131 after multiple doses	From admission to discharge, up to 12 days.	The area under the concentration-time curve from zero to the end of the dosing interval at steady state (AUCss) of VG290131 will be calculated after multiple doses from Day 1 to Day 7.
To evaluate PK parameter Rac of VG290131 after multiple doses	From admission to discharge, up to 12 days.	The accumulation ratio (Rac) of VG290131 will be calculated after multiple doses from Day 1 to Day 7.
To evaluate PK parameter Cmax,ss of VG290131 after multiple doses	From admission to discharge, up to 12 days.	The maximum observed concentration at steady state (Cmax,ss) of VG290131 will be calculated after multiple doses from Day 1 to Day 7.
To evaluate PK parameter Tmax of VG290131 after a single dose	From admission to discharge, up to 12 days.	Tmax of VG290131 under fasted and fed conditions will be calculated after a single dose.
To evaluate PK parameter AUC0-t of VG290131 after a single dose	From admission to discharge, up to 12 days.	AUC0-t of VG290131 under fasted and fed conditions will be calculated after a single dose.
To evaluate PK parameter AUC0-inf of VG290131 after a single dose	From admission to discharge, up to 12 days.	AUC0-inf of VG290131 under fasted and fed conditions will be calculated after a single dose.
To evaluate PK parameter t1/2 of VG290131 after a single dose	From admission to discharge, up to 12 days.	t1/2 of VG290131 under fasted and fed conditions will be calculated after a single dose.

Countries

Australia

Contacts

Primary ContactDr. Ana Liza Sun

asun@linear.org.au+61 8 6382 5100

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026