Healthy VolunteersPhase 1NCT06402513
A Study in Healthy Adult Participants to Assess the Pharmacokinetics, Immunogenicity, Safety, and Tolerability of a Ravagalimab Subcutaneous Formulation in a Pre-Filled Syringe
A Phase 1 study testing Ravagalimab in people with Healthy Volunteers, run by AbbVie at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Ravagalimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jun 2024to 8 Oct 2024
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Healthy Volunteers
- Being tested
- Ravagalimab
- Keywords
- Healthy Volunteers, Ravagalimab, ABBV-323
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RavagalimabDrug
Also called ABBV-323
Subcutaneous Injection
| Study group | Role | What they receive |
|---|---|---|
| Ravagalimab | Experimental | Participants will receive 2 (SC) subcutaneous injections of Ravagalimab via Pre-Filled Syringe at Day 1 and followed for 85 days Receives: Drug: Ravagalimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Plasma Concentration (Cmax)
Maximum Observed Plasma Concentration (Cmax)
Measured: Approximately up to 71 days
Time to Maximum Observed Plasma Concentration (Tmax)
Time to Maximum Observed Plasma Concentration (Tmax)
Measured: Approximately up to 71 days
Apparent Terminal Phase Elimination Rate Constant (β)
Apparent Terminal Phase Elimination Rate Constant (β)
Measured: Approximately up to 71 days
The Terminal Phase Elimination Half-Life (t1/2)
The Terminal Phase Elimination Half-Life (t1/2)
Measured: Approximately up to 71 days
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)
Measured: Approximately up to 71 days
The Area Under the Plasma Concentration-Time Curve (AUC) from Time 0 to Infinity (AUC∞)
The Area Under the Plasma Concentration-Time Curve (AUC) from Time 0 to Infinity (AUC∞)
Measured: Approximately up to 71 days
Number of Anti-drug antibody (ADA) Titers
Incidence of anti-drug antibodies
Measured: Approximately up to 71 days
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.
Measured: Approximately up to 85 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2024
- Study start24 Jun 2024
- Primary completion8 Oct 2024
- Study completion8 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06402513
- Sponsor's protocol ID
- M24-518
- Status last verified
- Oct 2024
- First submitted
- 3 May 2024
- Last updated
- 21 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No