COMBINATION_PRODUCT
abaloparatide-sMTS
Single-dose administration of abaloparatide 300 μg applied to the thigh for 5 minutes
Study to Evaluate and Compare the PK Profiles of Abaloparatide-SC and Abaloparatide-sMTS in a Cohort of Healthy Men and Healthy Women.
Status
Completed
Phase
Phase 1
Enrollment
52
Locations
1
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
A study to evaluate and compare the PK profiles of abaloparatide-SC 80 μg and abaloparatide-sMTS 300 μg in a cohort of healthy men and to make a similar evaluation in a cohort of healthy women
Full detailed description
This study aims to evaluate and compare the pharmacokinetic (PK) profiles of abaloparatide-SC 80 μg injected subcutaneously into the periumbilical region of the abdomen, and abaloparatide-sMTS 300 μg applied to the thigh for 5 minutes in a cohort of healthy men and to make a similar evaluation in a cohort of healthy women.
Interventions
Treatment arms and agents.
COMBINATION_PRODUCT
abaloparatide-SC
Single-dose administration of abaloparatide 80 μg subcutaneous injection to the periumbilical region of the abdomen
Timeline
From registration to results.
First posted
Dec 11, 2020
Study start
Nov 16, 2020
Primary completion
Mar 27, 2021
Study completion
Nov 19, 2021
Results posted
Not reported
Registry updated
Jan 6, 2022
Outcomes
What the study measures.
Primary outcomes
PK Cmax
Time frame · Time frame for collection of PK data after each single-dose administration, separated by 48 hours
Maximum observed concentration (Cmax)
PK AUC1
Time frame · Time frame for collection of PK data after each single-dose administration, separated by 48 hours
Area under the plasma concentration-time curve (AUC) from time 0 to the time of the last quantifiable concentration (AUC 0-t)
PK AUC2
Time frame · Time frame for collection of PK data after each single-dose administration, separated by 48 hours
AUC from time 0 extrapolated to time infinity (AUC 0-∞)
Secondary outcomes
Subjects with AEs and SAEs
Time frame · 10 Days
Subjects with treatment-emergent AEs and SAEs.
Eligibility
Who can take part.
- Minimum age
- 40 Years
- Maximum age
- 65 Years
- Sex
- ALL
- Healthy volunteers
- Yes
Inclusion Criteria * Male and female subjects aged 40 to 65 years old, inclusive, at Screening; * Good general health as determined by medical history and physical exam (including vital signs, and has a body mass index between 18 and 32 kg/m\^2; * Laboratory test results within the normal range * Serum 25-hydroxyvitamin D values must be \> 20 ng/mL. Exclusion Criteria: * Presence or history of any disorder that may prevent the successful completion of the study; * Diagnosed with osteoporosis, Paget's disease, or other metabolic bone diseases (eg, vitamin D deficiency or osteomalacia), or had a non-traumatic fracture within 1 year prior to the initial screening; * History of any cancer within the past 5 years other than squamous or basal cell carcinoma; * History of allergy to abaloparatide or drugs in a similar pharmacological class;.
Study locations
1 registered sites.
United States. Showing up to 24 locations stored in the fast local snapshot.
Medpace Clinical Pharmacology
Cincinnati, Ohio, United States
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
Related trials
More studies on Abaloparatide.
NCT IDStudyPhase / statusEnrollmentUpdated
The Effect of Osteoporotic Medications on Vertebral Bone Quality Score
State University of New York at Buffalo · Lumbar Degenerative Disease
Phase 2
Enrolling by invitation
60
2026-07
Sequential Therapies After Osteoanabolic Treatment
424 General Military Hospital · Osteoporosis, Postmenopausal
Not applicable
Recruiting
150
2026-07
Abaloparatide Added to Ongoing Denosumab vs Continued Denosumab Alone
Hospital for Special Surgery, New York · Osteoporosis, Postmenopausal
Phase 4
Active, not recruiting
70
2026-06
Abaloparatide Before Total Knee Arthroplasty
University of Wisconsin, Madison · Osteoporosis · Arthroplasties, Knee Replacement
Phase 4
Completed
58
2026-06
MicroRNA and Markers and Therapeutic Response to Romosozumab and Abaloparatide in Postmenopausal Osteoporosis
Istituto Auxologico Italiano · Osteoporosis · Menopause
Not applicable
Recruiting
42
2026-06
Abaloparatide vs. Placebo in Post-Menopausal Women and Abaloparatide in Men Receiving Initial Spinal Fusion Surgery
Hospital for Special Surgery, New York · Spinal Fusion
Phase 2
Active, not recruiting
96
2026-04
To Evaluate the Efficacy and Safety of Abaloparatide Injection (QLG2128) in the Treatment of Postmenopausal Women With Osteoporosis and at High Risk of Fracture
Qilu Pharmaceutical Co., Ltd. · Postmenopausal Women With Osteoporosis
Phase 3
Not yet recruiting
282
2025-03
A Single-center, Open, Randomized, Single-dose, Cross-over Bioequivalence Study to Evaluate the Effects of the Test Formulation Abalparatide Injection and the Reference Formulation Abalparatide Injection (Tymlos®) in Healthy Adult Subjects
The Affiliated Hospital of Qingdao University · Osteoporosis
Phase 1
Not yet recruiting
32
2024-12
Related PeptideStat pages
Put the record in context.
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.