A Study in Healthy Adult Participants to Assess the Pharmacokinetics, Immunogenicity, Safety, and Tolerability of a Ravagalimab Subcutaneous Formulation in a Pre-Filled Syringe

Healthy Volunteers Clinical Trial

Official title:

A Phase 1 Study in Healthy Adult Subjects to Evaluate the Pharmacokinetics, Immunogenicity, Safety, and Tolerability of a Ravagalimab Subcutaneous Formulation in a Pre-Filled Syringe

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06402513
• Other study ID #: M24-518
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: June 24, 2024
• Est. completion date: October 9, 2024

Study information

• Verified date: May 2024
• Source: AbbVie
• Contact: ABBVIE CALL CENTER
• Phone: 844-663-3742
• Email: abbvieclinicaltrials[@]abbvie.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to assess the pharmacokinetics, immunogenicity, safety, and tolerability, of subcutaneous formulation of ravagalimab in a pre-filled syringe in healthy adult participants.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 12
• Est. completion date: October 9, 2024
• Est. primary completion date: October 9, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Body Mass Index (BMI) is = 18.0 to = 29.9 kg/m^2 after rounding to the tenth decimal at screening.

• A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead ECG.

Exclusion Criteria:

• History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.

• Participant using any over the counter and/or prescription medication, vitamins and/or herbal supplements, with the exception contraceptives or hormonal replacement therapies for females, on a regular basis.

• History of any clinically significant sensitivity or allergy to any medication or food.

• No prior exposure to ravagalimab

• Participant using any medications, vitamins, and/or herbal supplements within the 2-week period or 5 half-lives (whichever is longer) prior to study drug administration.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Ravagalimab
Subcutaneous Injection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Observed Plasma Concentration (Cmax)	Maximum Observed Plasma Concentration (Cmax)	Approximately up to 71 days
Primary	Time to Maximum Observed Plasma Concentration (Tmax)	Time to Maximum Observed Plasma Concentration (Tmax)	Approximately up to 71 days
Primary	Apparent Terminal Phase Elimination Rate Constant (ß)	Apparent Terminal Phase Elimination Rate Constant (ß)	Approximately up to 71 days
Primary	The Terminal Phase Elimination Half-Life (t1/2)	The Terminal Phase Elimination Half-Life (t1/2)	Approximately up to 71 days
Primary	The Area Under the Plasma Concentration-Time Curve (AUC) from Time 0 to Time of the Last Measurable Concentration (AUCt)	The Area Under the Plasma Concentration-Time Curve (AUC) from Time 0 to Time of the Last Measurable Concentration (AUCt)	Approximately up to 71 days
Primary	The Area Under the Plasma Concentration-Time Curve (AUC) from Time 0 to Infinity (AUC8)	The Area Under the Plasma Concentration-Time Curve (AUC) from Time 0 to Infinity (AUC8)	Approximately up to 71 days
Primary	Number of Anti-drug antibody (ADA) Titers	Incidence of anti-drug antibodies	Approximately up to 71 days
Primary	Number of Participants with Adverse Events	An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study.	Approximately up to 85 days

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