Study Evaluating PK of PTH Administered Orally Via RaniPill™ Capsule

Healthy Volunteers Clinical Trial

Official title: A Phase I Study to Evaluate the Pharmacokinetics of Parathyroid Hormone (1-34) Administered Orally Via RaniPill™ Capsule

Status Completed

Clinical Trial Summary

A prospective, single-center, open-label, phase I study evaluating the pharmacokinetics (PK) of human parathyroid hormone (1-34) ("PTH") administered via the RaniPill™ capsule ("RT-102").

Clinical Trial Description

The RaniPill device is a capsule-like ingestible device, which injects a microneedle containing a micro tablet (payload/drug) into the intestinal wall. This is a single-center, prospective, open-label, feasibility study being conducted in two parts.

Part 1: Healthy women volunteers, 18-65 years of age, of any race, recruited from the general population and assigned to one of the following groups:

RT-102:

• RT-102 Group 1: 20 µg (N=15)

• RT-102 Group 2: 80 µg (N=15)

Subcutaneous (SC):

• SC Group: 20 µg of Forteo (N=10)

Part 2: Healthy women, 18-65 years of age, or healthy post-menopausal or surgically sterile with bilateral oophorectomy women of any race, recruited from the general population will have once-a-day repeat dosing with 20 μg dose of RT-102 for 7 days (N= up to 12):

• Healthy women: N = up to 12

• Post-menopausal or surgically sterile volunteers: N = up to 7 ;

Related Conditions & MeSH terms

• Healthy Volunteers

• NCT number: NCT05164614
• Study type: Interventional
• Source: RANI Therapeutics
• Status: Completed
• Phase: Phase 1
• Start date: February 21, 2022
• Completion date: October 17, 2022