| Eligibility |
Inclusion Criteria:
Part 1
1. Participant understands and voluntarily signs the approved informed consent document
prior to the performance of any study-specific procedures
2. Willing to comply with all study procedures and available for the entire duration of
the study
3. Participant is ambulatory female between 18 to 65 years of age.
4. BMI between 19 to 32 kg/m2.
5. In good health, determined by no clinically significant findings from medical history,
physical examination, laboratory tests, and vital signs.
6. Non-menstruating, non-pregnant or non-lactating women during study participation NOTE:
Females who are of childbearing potential must have had a negative pregnancy test on
day of screening. Contraception (double barrier contraception and be protected by a
daily combination birth control pill containing estrogen and progestin or any other
form of hormonal contraceptive if cannot use the contraceptive pill) should be used
between Screening visit and 30 days after dosing if actively engaged in penile-vaginal
intercourse.
Part 2: Healthy Women
1. Participant understands and voluntarily signs the approved informed consent document
prior to the performance of any study-specific procedures
2. Willing to comply with all study procedures and available for the entire duration of
the study
3. Participant is ambulatory female between 18 to 65 years of age.
4. BMI between 19 to 32 kg/m2.
5. In good health, determined by no clinically significant findings from medical history,
physical examination, laboratory tests, and vital signs.
6. Non-menstruating, non-pregnant or non-lactating women during study participation NOTE:
Females who are of childbearing potential must have had a negative pregnancy test on
day of screening. A double barrier approach using highly effective methods of
contraception (e.g., oral contraceptives containing combined estrogen and
progesterone, a vaginal ring, injectable and implantable hormonal contraceptives,
intrauterine hormone-releasing system [e.g., Mirena], progestogen-only hormonal
contraception associated with inhibition of ovulation, nonhormonal intrauterine
device, bilateral tubal occlusion) should be used between Screening visit and 30 days
after dosing if actively engaged in penile-vaginal intercourse.
Part 2: Post-menopausal/surgically sterile
1. Participant understands and voluntarily signs the approved informed consent document
prior to the performance of any study-specific procedures
2. Willing to comply with all study procedures and available for the entire duration of
the study
3. Healthy ambulatory female post-menopausal for at least 1 year or surgically sterile
with bilateral oophorectomy
4. BMI between 19 to 32 kg/m2.
5. In good health, determined by no clinically significant findings from medical history,
physical examination, laboratory tests, and vital signs.
Exclusion Criteria:
Part 1
1. Participants with known history of chronic constipation, gastroparesis / delayed
gastric emptying, gastric or duodenal ulcers, dysphagia, dyspepsia, esophagitis,
esophageal spasm, GERD, IBD, Crohn's disease, stomas, tumors, ischemic or ulcerative
colitis
2. Participant has known history of intolerance of PTH (1-34)
3. Participant has known history of high levels of uric acid outside normal ranges
4. Participant has known history of osteoporosis or other bone disorders (such as Paget's
disease)
5. Participant has known history of Cushing's disease, hypo- or hyper-parathyroidism or
malabsorptive syndromes within the past year
6. Participant is taking calcium and/or vitamin D supplements within 7 days of treatment
(including multi-vitamins containing calcium and/or vitamin D)
7. Participant has febrile illness within 30 days of the study procedures
8. Participant currently treated with parathyroid hormone, parathyroid hormone-related
peptide-derived drugs, or bone anabolic steroids, including abaloparatide,
teriparatide, or parathyroid hormone (1-84)
9. Participant currently treated with intravenous bisphosphonates for at least 1 month or
oral bisphosphonates within the past year (12 months). Subjects who have received a
short course of oral bisphosphonate therapy (3 months or less) may be enrolled if the
treatment occurred 6 or more months prior to enrollment
10. Participants on a regimen of proton pump inhibitors (e.g. omeprazole) or histamine H2
receptor antagonists (e.g. ranitidine)
11. Participants with known bowel obstruction/stricture/fistula
12. Participants who have undergone gastrointestinal surgery (Roux-en-Y, Billroth II,
Whipple, intestinal resection for any reason)
13. Participants who have undergone a recent (less than a month) barium X-ray procedure
14. Participants with known allergies or sensitivity to contrast media or barium sulfate
15. Participant with history of chronic disease that in the investigator's judgement may
impact subject safety or study outcomes
16. Participants with congestive heart failure, renal failure
17. Presence of cardiac pacemaker or implanted electromedical device
18. Participant who is pregnant or lactating
19. Participant has received an investigational or marketed drug during a trial within the
past 1 month or 5 half-lives of the investigational drug, whichever is longer
20. Participant received COVID-19 vaccine within 7 days of dosing
21. Participant is unlikely, in the investigator's judgment, to be able to complete
participation in the study as required per study plan
22. Any other history which, in the investigator's judgment, makes the participant
ineligible or places the participant at risk
Part 2: Healthy Women
1. Participants with known history of chronic constipation, gastroparesis / delayed
gastric emptying, gastric or duodenal ulcers, dysphagia, dyspepsia, esophagitis,
esophageal spasm, GERD, IBD, Crohn's disease, stomas, tumors, ischemic or ulcerative
colitis
2. Participant has known history of intolerance of PTH (1-34)
3. Participant has known history of high levels of uric acid outside normal ranges
4. Participant has known history of osteoporosis or other bone disorders (such as Paget's
disease)
5. Participant has known history of Cushing's disease, hypo- or hyper-parathyroidism or
malabsorptive syndromes within the past year
6. Participant is taking calcium and/or vitamin D supplements within 7 days of treatment
(including multi-vitamins containing calcium and/or vitamin D)
7. Participant has febrile illness within 30 days of the study procedures
8. Participant currently treated with parathyroid hormone, parathyroid hormone-related
peptide-derived drugs, or bone anabolic steroids, including abaloparatide,
teriparatide, or parathyroid hormone (1-84)
9. Participant currently treated with intravenous bisphosphonates for at least 1 month or
oral bisphosphonates within the past year (12 months). Subjects who have received a
short course of oral bisphosphonate therapy (3 months or less) may be enrolled if the
treatment occurred 6 or more months prior to enrollment
10. Participants on a higher than the lowest approved therapeutic dose regimen of proton
pump inhibitors (see Section 8.3.9 for details)
11. Participants on a H2 receptor antagonists (e.g. ranitidine)
12. Participants with known bowel obstruction/stricture/fistula
13. Participants who have undergone gastrointestinal surgery (Roux-en-Y, Billroth II,
Whipple, intestinal resection for any reason)
14. Participants who have undergone a recent (less than a month) barium X-ray procedure
15. Participants with known allergies or sensitivity to contrast media or barium sulfate
16. Participant with history of chronic disease that in the investigator's judgement may
impact subject safety or study outcomes
17. Participants with congestive heart failure, renal failure
18. Presence of cardiac pacemaker or implanted electromedical device
19. Participant who is pregnant or lactating
20. Participant has received an investigational or marketed drug during a trial within the
past 1 month or 5 half-lives of the investigational drug, whichever is longer
21. Participant received COVID-19 vaccine within 7 days of dosing
22. Participant is unlikely, in the investigator's judgment, to be able to complete
participation in the study as required per study plan
23. Any other history which, in the investigator's judgment, makes the participant
ineligible or places the participant at risk
Part 2: Post-menopausal/surgically sterile
1. Participants with known history of chronic constipation, gastroparesis / delayed
gastric emptying, gastric or duodenal ulcers, dysphagia, dyspepsia, esophagitis,
esophageal spasm, GERD, IBD, Crohn's disease, stomas, tumors, ischemic or ulcerative
colitis
2. Participant has known history of intolerance of PTH (1-34)
3. Participant has known history of high levels of uric acid outside normal ranges
4. Participant has known history of osteoporosis or other bone disorders (such as Paget's
disease)
5. Participant has known history of Cushing's disease, hypo- or hyper-parathyroidism or
malabsorptive syndromes within the past year
6. Participant is taking calcium and/or vitamin D supplements within 7 days of treatment
(including multi-vitamins containing calcium and/or vitamin D)
7. Participant has febrile illness within 30 days of the study procedures
8. Participant currently treated with parathyroid hormone, parathyroid hormone-related
peptide-derived drugs, or bone anabolic steroids, including abaloparatide,
teriparatide, or parathyroid hormone (1-84)
9. Participant currently treated with intravenous bisphosphonates for at least 1 month or
oral bisphosphonates within the past year (12 months). Subjects who have received a
short course of oral bisphosphonate therapy (3 months or less) may be enrolled if the
treatment occurred 6 or more months prior to enrollment
10. Participants on a higher than the lowest approved therapeutic dose regimen of proton
pump inhibitors (see Section 8.3.9 for details)
11. Participants on a H2 receptor antagonists (e.g. ranitidine)
12. Participants with known bowel obstruction/stricture/fistula
13. Participants who have undergone gastrointestinal surgery (Roux-en-Y, Billroth II,
Whipple, intestinal resection for any reason)
14. Participants who have undergone a recent (less than a month) barium X-ray procedure
15. Participants with known allergies or sensitivity to contrast media or barium sulfate
16. Participant with history of chronic disease that in the investigator's judgement may
impact subject safety or study outcomes
17. Participants with congestive heart failure, renal failure
18. Presence of cardiac pacemaker or implanted electromedical device
19. Participant has received an investigational or marketed drug during a trial within the
past 1 month or 5 half-lives of the investigational drug, whichever is longer
20. Participant received COVID-19 vaccine within 7 days of dosing
21. Participant is unlikely, in the investigator's judgment, to be able to complete
participation in the study as required per study plan
22. Any other history which, in the investigator's judgment, makes the participant
ineligible or places the participant at risk
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