NCT06558097

Brief Summary

This study was a randomized, participant and investigator-blinded, placebo-controlled, single-ascending dose study, consisting of 9 sequential dose cohorts (1 mg, 3 mg, 10 mg, 30 mg, 60 mg, 120 mg, 240 mg, 450 mg and 600 mg) and a Japanese ethnic sensitivity cohort (240 mg dose)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
77

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jul 2020

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 29, 2020

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 2, 2023

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

August 14, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 16, 2024

Completed
Last Updated

August 16, 2024

Status Verified

August 1, 2024

Enrollment Period

2.6 years

First QC Date

August 14, 2024

Last Update Submit

August 14, 2024

Conditions

XXB750 in Healthy Participants

Keywords

XXB750healthy participants

Outcome Measures

Primary Outcomes (1)

  • Number of participants with Adverse Events

    To evaluate the safety and tolerability of single ascending SC doses of XXB750 in healthy participants. Adverse events may include abnormal vital signs, safety laboratory tests, physical exam tests and ECG parameters that include clinical signs or symptoms, are considered clinically significant or require therapy.

    Up to 121 days

Secondary Outcomes (7)

  • Pharmacokinetics parameters: Tmax

    Up to 91 days

  • Pharmacokinetics parameters: Cmax

    Up to 91 days

  • Pharmacokinetics parameters: AUClast

    Up to 91 days

  • Pharmacokinetics parameters: AUCinf

    Up to 91 days

  • Pharmacokinetics parameters: T1/2

    Up to 91 days

  • +2 more secondary outcomes

Study Arms (13)

XXB750 s.c 1 mg

EXPERIMENTAL

Single SC dose of XXB750 1 mg

Drug: XXB750

XXB750 s.c 3 mg

EXPERIMENTAL

Single SC dose of XXB750 3 mg

Drug: XXB750

XXB750 s.c 10 mg

EXPERIMENTAL

Single SC dose of XXB750 10 mg

Drug: XXB750

XXB750 s.c 30 mg

EXPERIMENTAL

Single SC dose of XXB750 30 mg

Drug: XXB750

XXB750 s.c 60 mg

EXPERIMENTAL

Single SC dose of XXB750 60 mg

Drug: XXB750

XXB750 s.c 120 mg

EXPERIMENTAL

Single SC dose of XXB750 120 mg

Drug: XXB750

XXB750 s.c 240 mg

EXPERIMENTAL

Single SC dose of XXB750 240 mg

Drug: XXB750

Placebo

PLACEBO COMPARATOR

Placebo to XXB750

Other: Placebo

XXB750 s.c 240 mg Japanese cohort

EXPERIMENTAL

Single SC dose of XXB750 240 mg in the Japanese cohort

Drug: XXB750

Placebo for Japanese cohort

PLACEBO COMPARATOR

Placebo to XXB750 in the Japanese cohort

Other: Placebo

XXB750 s.c 450 mg (HBP)

EXPERIMENTAL

Single SC dose of XXB750 450 mg (High Blood Pressure Cohort)

Drug: XXB750

XXB750 s.c 600 mg (HBP)

EXPERIMENTAL

Single SC dose of XXB750 600 mg (High Blood Pressure Cohort)

Drug: XXB750

Placebo to High Blood Pressure cohort

PLACEBO COMPARATOR

Placebo to XXB750 in High Blood Pressure cohorts

Other: Placebo

Interventions

XXB750DRUG

Single SC dose of XXB750 (administered by single or multiple injections)

XXB750 s.c 1 mgXXB750 s.c 10 mgXXB750 s.c 120 mgXXB750 s.c 240 mgXXB750 s.c 240 mg Japanese cohortXXB750 s.c 3 mgXXB750 s.c 30 mgXXB750 s.c 450 mg (HBP)XXB750 s.c 60 mgXXB750 s.c 600 mg (HBP)
PlaceboOTHER

Single SC dose of matching placebo (administered by single or multiple injections)

PlaceboPlacebo for Japanese cohortPlacebo to High Blood Pressure cohort

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male and female participants age 18 to 50 years of age included, and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening.
  • Participants must weigh at least 50 kg to participate in the study, and must have a body mass index (BMI) within the range of 18 - 32 kg/m2. BMI = Body weight (kg) / \[Height (m)\]2
  • For ethnic Japanese cohort: participants must be defined as being of first, second or third generation ethnic origin, with each set of parents qualifying as Japanese under the prior generation.

You may not qualify if:

  • Any surgical or medical condition which significantly altered the distribution, metabolism, or excretion of drugs, or which jeopardized the participant's participation in the study.
  • Known history or current clinically significant arrhythmias.
  • Women of child-bearing potential were excluded from this study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis Investigative Site

Cypress, California, 90630, United States

Location

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

August 14, 2024

First Posted

August 16, 2024

Study Start

July 29, 2020

Primary Completion

March 2, 2023

Study Completion

March 31, 2023

Last Updated

August 16, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)