Xla1 Christensenella Minuta, Phase I, Randomized, Partially Placebo-controlled Double-blind Protocol, Evaluating Safety, Tolerability and Impact on the Gut Microbiota in Healthy Volunteers, Overweight and Obese Adults

NCT04663139 | Completed Phase 1 FDA Drug

• 1 other identifier: CAUSALITY
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

Xla1 Christensenella minuta, phase I, randomized, placebo-controlled double-blind protocol, evaluating safety, tolerability and impact on the gut microbiota in healthy volunteers, overweight and obese adults. This study is designed as a FIH, Phase I, daily oral single dose, clinical trial evaluating safety, tolerability and the impact on the gut microbiota following introduction of Xla1 performed in 2 parts:

• Part 1: An open phase in normal weight healthy volunteers (HV) receiving all Xla1.
• Part 2: A randomized, parallel, double-blind, placebo-controlled phase in overweight or obese (stage 1) adult patients receiving either Xla1 or placebo.

Conditions

Obesity; Metabolic Disease

Keywords

obesity; LBP; Xla1

Outcome Measures

Primary Outcomes (1)

• number of patients experiencing adverse events

  To assess the safety and tolerability of Xla1 in Healthy adult Volunteers (HV) \[part 1\], and, subsequently, in overweight and class I obese adults \[part 2\].

  12 weeks

Secondary Outcomes (2)

• Modulation of the gut microbiota composition

  12 weeks

• Quantification of Xla1 presence in stools during the study

  12 weeks

Study Arms (3)

normal weight healthy adult volunteers receiving Xla1

EXPERIMENTAL

one capsule Xla1 given once daily

Drug: Xla1

overweight and class 1 obese adult patients receiving Xla1

EXPERIMENTAL

one capsule Xla1 given once daily

Drug: Xla1

overweight and class 1 obese adult patients receiving placebo

PLACEBO COMPARATOR

one capsule placebo given once daily

Drug: Placebo

Interventions

Xla1 DRUG

Xla1 is a Live Biotherapeutic Product (LBP) containing a strain of the bacteria Christensenella minuta (C. minuta)

normal weight healthy adult volunteers receiving Xla1; overweight and class 1 obese adult patients receiving Xla1

Placebo DRUG

Matching placebo

Also known as: Matching placebo

overweight and class 1 obese adult patients receiving placebo

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female or male
• Age between 19 and 65 years
• BMI between 18.5 and 24.9 kg/m²
• Good general and mental health state without clinically significant abnormalities in medical history, confirmed by physical examination
• Female subjects who are heterosexually active and of childbearing potential (e.g., not surgically sterile at least 6 months prior to first dose or naturally postmenopausal for at least 1 year prior to the first dose) must have been using one of the following forms of contraception and agree to continue using it through completion of the study:
• hormonal (e.g., oral, vaginal ring, transdermal patch, implant, injection) consistently for at least 3 months prior to first dose,
• double barrier (i.e., condom with spermicide or diaphragm with spermicide) consistently for at least 2 weeks prior to first dose,
• intrauterine device for at least 3 months prior to first dose, exclusive partner who has been vasectomized for at least 6 months (inclusive) prior to first dose.
• Female subjects of childbearing potential who are not currently engaging in heterosexual intercourse must agree to use one of the above methods of birth control, in the event that they have heterosexual intercourse during the course of the study (and until the final study visit) :
• Female subjects who are of non-childbearing potential must have undergone one of the following sterilization procedures at least 6 months prior to first dose:
• hysteroscopic sterilization;
• bilateral tubal ligation or bilateral salpingectomy;
• hysterectomy;
• bilateral oophorectomy;
• Transcervical sterilization or tubal occlusion (e.g., Essure® implantation)

You may not qualify if:

• Simultaneous participation in other clinical trials or previous participation within 30 days before randomization
• Any clinically confirmed congenital or acquired metabolic disorder incompatible with the conduct of the study by the investigator's opinion (including but not limited to: diabetes, hypothyroidism, familial hypercholesterolemia, etc.) Subjects with hypothyroidism on a stable dose of levothyroxine for at least 3 months and with a TSH in the normal range at screening may participate.
• Clinically significant cardiac, inflammatory, renal, gastrointestinal or cerebrovascular disorder, as judged by the investigator.
• Blood Pressure of ≥140/90 mmHg, Oral Temperature of ≥37.8°C, Pulse Rate of ≥100 bpm, at screening after 5 minutes of rest in the supine position. All screened subject with a blood pressure of ≥140/90 mmHg will be referred to their primary care physician.
• Medical history of any type of cancer except for squamous cell or basal cell skin carcinoma or uterine cervix carcinoma in situ treated surgically by local excision at least twenty-four weeks (6 months) prior to enrollment
• Major surgical procedure within the last 6 months or planned during the study
• Any history of Bariatric surgery
• Patients with a history of hypersensitivity to the investigational product or its excipients (Xla1 or placebo)
• Genetic obesity, i.e. obesity secondary to a genetic or medical condition, such as polycystic ovarian syndrome, hypothyroidism, Cushing's syndrome, growth hormone deficiency, insulinoma, hypothalamic disorders (e.g., Froelich syndrome, Bardet-Biedl syndrome, Prader-Willi syndrome), or use of any medication known to impact body weight within the last 6 months(e.g., antipsychotics).
• Clinically significant laboratory abnormalities as judged by the investigstor
• Patients with known positive serology for Human Immunodeficiency Virus - 1 or 2, Hepatitis B Virus or Hepatitis C Virus
• Pregnant or lactating women
• Concomitant treatment or medical history of treatment (in the last 6 months prior to enrollment) with drugs considered as acting on body weight such as:
• Anticonvulsants
• Anti-HIV therapy

Sponsors & Collaborators

• YSOPIA Bioscience: lead

Study Sites (1)

Celerion

Lincoln, Nebraska, 68502, United States

Location

MeSH Terms

Conditions

Obesity; Metabolic Diseases

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The randomization list will be generated by a statistician not involved in the study using randomly permuted blocks and will be stratified by BMI category (overweight or obese) and sex.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This study is designed as a First in Human, Phase I, clinical trial evaluating safety, tolerability and the impact on the gut microbiota of Xla1. The study will be performed in 2 parts: Part 1: An open label phase in normal weight healthy adult volunteers receiving Xla1. Part 2: A randomized, parallel, double-blind, placebo-controlled phase I in overweight and class 1 obese adult patients receiving either Xla1 or placebo.

Study Record Dates

• First Submitted: December 3, 2020
• First Posted: December 10, 2020
• Study Start: November 1, 2020
• Primary Completion: June 26, 2021
• Study Completion: June 26, 2021
• Last Updated: July 13, 2021

Record last verified: 2021-07

Locations

US (1)