A Phase 1 Study to Evaluate Safety and Tolerability of Single and Multiple Ascending Doses of XEN-101

NCT05667129 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: XB22-001
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to assess the safety and tolerability of single and multiple ascending doses of XEN-101

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• The frequency of adverse events (Safety of XEN-101)

  assessing the type and frequency of adverse events

  From Day 1 through end of study (Day 7 SAD; Day 38 MAD)

Study Arms (2)

XEN-101

EXPERIMENTAL

Capsule formulation

Drug: XEN-101

Placebo

PLACEBO COMPARATOR

Capsule formulation

Drug: Placebo

Interventions

XEN-101 DRUG

Capsule formulation

XEN-101

Placebo DRUG

capsule formulation

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female, age 18-60 years at Screening
• SAD part: BMI 18-30 kg/m2; MAD part 2a: BMI 22-27 kg/m2; MAD Part 2b: BMI 30-40 kg/m2
• Stable body weight for at least 3 months (fluctuation of less than or equal to 5% and not exceeding 4 kg) in all study Parts.
• Women of childbearing potential shall agree to use an adequate method of contraception from the date of signing of the informed consent, throughout the study, and for 4 weeks after the final (EOS) study visit. In addition, they must be advised not to donate ova during this period. From the date of signing of the informed consent, throughout the study, and for 8 weeks after the last dose of study medication, non sterilized male subjects who are sexually active with a female partner of childbearing potential must use barrier contraception (e.g., condom with spermicidal cream or jelly). In addition, they must be advised not to donate sperm during this period.
• Females of childbearing potential must have a negative pregnancy test at Screening and on Day -1 (baseline)
• Able to provide Informed Consent
• Willing and able to comply with this protocol and procedures, including feces pro-cessing and be available for the entire duration of the study.

You may not qualify if:

• Currently enrolled in another investigational device or drug study, or less than 30 days or 5 time the half-life of the drug candidate, whichever is longer, passed at Screening since ending the treatment period the previous investigational device or drug study
• History of diabetes mellitus, hypertension, sleep apnea, liver, kidney, auto-immune disease
• Current nicotine use or in past 6 months (smoking, vaping, etc)
• Uncontrolled psychiatric disorder
• History of eating disorder (e.g. anorexia nervosa, bulimia, binge-eating disorder)
• History of alcohol, nicotine, or substance misuse in the last 5 years
• Use of antibiotics, antivirals, antifungals during past 3 months
• Use of proton pump inhibitors or non-stable dose antidepressants
• Use of anti-obesity medications (e.g. GLP-analogues, stimulants, bupropri-on/naltrexone, etc.)
• Use of obesogenic medications (e.g. anti-diabetics, anti-convulsives, anti-histamines, beta-blockers, etc.) in past 3 months

Sponsors & Collaborators

• Xeno Biosciences: lead

Study Sites (1)

CRU Hungary - Early Phase Unit

Kistarcsa, Hungary

Location

Study Officials

• Geza Lakner, MD

  Clinical Research Units Hungary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2022
• First Posted: December 28, 2022
• Study Start: December 1, 2022
• Primary Completion: May 30, 2023
• Study Completion: May 30, 2023
• Last Updated: July 20, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1)