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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: XEN-101; Drug: Placebo

Detailed Description

Single ascending dose (SAD) study to evaluate the safety and tolerability of XEN-101 in healthy participants. Multiple ascending dose (MAD) study to evaluate the safety and tolerability of XEN-101 in healthy participants.

• Study Type: Interventional
• Enrollment (Actual): 97
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: David Beno, PhD; Phone Number: 8338073142; Email: administrator@xenobiosciences.com

Study Locations

• Hungary
  • Kistarcsa, Hungary
    • CRU Hungary - Early Phase Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Male or female, age 18-60 years at Screening
2. SAD part: BMI 18-30 kg/m2; MAD part 2a: BMI 22-27 kg/m2; MAD Part 2b: BMI 30-40 kg/m2
3. 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.
4. 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.
5. Females of childbearing potential must have a negative pregnancy test at Screening and on Day -1 (baseline)
6. Able to provide Informed Consent
7. Willing and able to comply with this protocol and procedures, including feces pro-cessing and be available for the entire duration of the study.

Exclusion Criteria:

1. 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
2. History of diabetes mellitus, hypertension, sleep apnea, liver, kidney, auto-immune disease
3. Current nicotine use or in past 6 months (smoking, vaping, etc)
4. Uncontrolled psychiatric disorder
5. History of eating disorder (e.g. anorexia nervosa, bulimia, binge-eating disorder)
6. History of alcohol, nicotine, or substance misuse in the last 5 years
7. Use of antibiotics, antivirals, antifungals during past 3 months
8. Use of proton pump inhibitors or non-stable dose antidepressants
9. Use of anti-obesity medications (e.g. GLP-analogues, stimulants, bupropri-on/naltrexone, etc.)
10. Use of obesogenic medications (e.g. anti-diabetics, anti-convulsives, anti-histamines, beta-blockers, etc.) in past 3 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Capsule formulation	Drug: Placebo; capsule formulation
Experimental: XEN-101; Capsule formulation	Drug: XEN-101; Capsule formulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Xeno Biosciences
• Investigators: Principal Investigator: Geza Lakner, MD, CRU Hungary Kft

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2022
• Primary Completion (Actual): May 30, 2023
• Study Completion (Actual): May 30, 2023

Study Registration Dates

• First Submitted: December 19, 2022
• First Submitted That Met QC Criteria: December 27, 2022
• First Posted (Actual): December 28, 2022

Study Record Updates

• Last Update Posted (Actual): July 20, 2023
• Last Update Submitted That Met QC Criteria: July 19, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: XB22-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes