CClinicalTrials.gg
Sign In
CompletedNCT05667129Updated Jul 20, 2023

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

A Phase 1 interventional study of XEN-101 and Placebo in Healthy, sponsored by Xeno Biosciences. Completed at 1 site in Hungary. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-20.

Sponsored by Xeno Biosciences · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was May 2023, 3 years 4 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
97
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

This is the only study on the registry with Xeno Biosciences as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
97 participants (actual)

Study arms

  • Experimental
    XEN-101

    Capsule formulation

    Drug: XEN-101

  • Placebo comparator
    Placebo

    Capsule formulation

    Drug: Placebo

Interventions

  • DrugXEN-101

    Capsule formulation

  • DrugPlacebo

    capsule formulation

06

What researchers measure

Primary outcomes

  1. The frequency of adverse events (Safety of XEN-101)

    assessing the type and frequency of adverse events

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

07

Study locations

1 site
  • CRU Hungary - Early Phase Unit
    Kistarcsa, Hungary
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 20, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05667129
Lead sponsor
Xeno Biosciences
Responsible party
Sponsor
First posted
Dec 28, 2022
Start date
Dec 1, 2022
Primary completion
May 30, 2023
Completion
May 30, 2023
Last update
Jul 20, 2023

Study contacts

Geza Lakner, MD
principal investigator · CRU Hungary Kft

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion