Trial Outcomes & Findings for A First Human Study of a Ferroportin Antibody (NCT NCT01330953)
NCT ID: NCT01330953
Last Updated: 2018-07-30
Results Overview
A clinically significant effect/event was defined as an adverse event (AE). A listing of serious and non-serious AEs is located in the Reported Adverse Event Module.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
32 participants
Primary outcome timeframe
Baseline through Day 85
Results posted on
2018-07-30
Participant Flow
Participant milestones
| Measure |
Placebo
Single intravenous placebo dose.
|
30 mg LY2928057
Day 1: single 30-mg LY2928057 intravenous dose; Days 2 and 3: observation period; Days 4 and 5: single 30-mg LY2928057 intravenous dose followed by 24-hour observation period; Days 6 and 7: single 30-mg LY2928057 intravenous dose; Days 8-85: participant follow-up for minimum of 12 weeks to assess the safety, immunogenicity, and pharmacokinetic profile of 30 mg LY2928057.
|
100 mg LY2928057
Day 1: single 100-mg LY2928057 intravenous dose; Days 2 and 3: observation period; Days 4 and 5: single 100-mg LY2928057 intravenous dose followed by 24-hour observation period; Days 6 and 7: single 100-mg LY2928057 intravenous dose; Days 8-85: participant follow-up for minimum of 12 weeks to assess the safety, immunogenicity, and pharmacokinetic profile of 100 mg LY2928057.
|
300 mg LY2928057
Day 1: single 300-mg LY2928057 intravenous dose; Days 2 and 3: observation period; Days 4 and 5: 1 participant receives single 300-mg LY2928057 intravenous dose followed by 24-hour observation period; Days 6 and 7: single 300-mg LY2928057 intravenous dose; Days 8-85: participant follow-up for minimum of 12 weeks to assess the safety, immunogenicity, and pharmacokinetic profile of 300 mg LY2928057.
|
1000 mg LY2928057
Day 1: single 1000-mg LY2928057 intravenous dose; Days 2 and 3: observation period; Days 4 and 5: single 1000-mg LY2928057 intravenous dose followed by 24-hour observation period; Days 6 and 7: single 1000-mg LY2928057 intravenous dose; Days 8-85: participant follow-up for minimum of 12 weeks to assess the safety, immunogenicity, and pharmacokinetic profile of 1000 mg LY2928057.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
6
|
6
|
6
|
6
|
|
Overall Study
COMPLETED
|
8
|
6
|
6
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A First Human Study of a Ferroportin Antibody
Baseline characteristics by cohort
| Measure |
Placebo
n=8 Participants
Single intravenous placebo dose.
|
30 mg LY2928057
n=6 Participants
Day 1: single 30-mg LY2928057 intravenous dose; Days 2 and 3: observation period; Days 4 and 5: single 30-mg LY2928057 intravenous dose followed by 24-hour observation period; Days 6 and 7: single 30-mg LY2928057 intravenous dose; Days 8-85: participant follow-up for minimum of 12 weeks to assess the safety, immunogenicity, and pharmacokinetic profile of 30 mg LY2928057.
|
100 mg LY2928057
n=6 Participants
Day 1: single 100-mg LY2928057 intravenous dose; Days 2 and 3: observation period; Days 4 and 5: single 100-mg LY2928057 intravenous dose followed by 24-hour observation period; Days 6 and 7: single 100-mg LY2928057 intravenous dose; Days 8-85: participant follow-up for minimum of 12 weeks to assess the safety, immunogenicity, and pharmacokinetic profile of 100 mg LY2928057.
|
300 mg LY2928057
n=6 Participants
Day 1: single 300-mg LY2928057 intravenous dose; Days 2 and 3: observation period; Days 4 and 5: 1 participant receives single 300-mg LY2928057 intravenous dose followed by 24-hour observation period; Days 6 and 7: single 300-mg LY2928057 intravenous dose; Days 8-85: participant follow-up for minimum of 12 weeks to assess the safety, immunogenicity, and pharmacokinetic profile of 300 mg LY2928057.
|
1000 mg LY2928057
n=6 Participants
Day 1: single 1000-mg LY2928057 intravenous dose; Days 2 and 3: observation period; Days 4 and 5: single 1000-mg LY2928057 intravenous dose followed by 24-hour observation period; Days 6 and 7: single 1000-mg LY2928057 intravenous dose; Days 8-85: participant follow-up for minimum of 12 weeks to assess the safety, immunogenicity, and pharmacokinetic profile of 1000 mg LY2928057.
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
36.0 years
STANDARD_DEVIATION 13.8 • n=5 Participants
|
33.5 years
STANDARD_DEVIATION 14.8 • n=7 Participants
|
31.0 years
STANDARD_DEVIATION 6.3 • n=5 Participants
|
40.2 years
STANDARD_DEVIATION 11.7 • n=4 Participants
|
27.0 years
STANDARD_DEVIATION 6.1 • n=21 Participants
|
33.7 years
STANDARD_DEVIATION 11.5 • n=8 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
31 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Asian
|
8 participants
n=5 Participants
|
6 participants
n=7 Participants
|
6 participants
n=5 Participants
|
6 participants
n=4 Participants
|
6 participants
n=21 Participants
|
32 participants
n=8 Participants
|
|
Region of Enrollment
Singapore
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
32 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Baseline through Day 85Population: The analysis population included all randomized participants dosed with placebo or LY2928057, and who provided safety data at least up to and including the Day 8 assessment.
A clinically significant effect/event was defined as an adverse event (AE). A listing of serious and non-serious AEs is located in the Reported Adverse Event Module.
Outcome measures
| Measure |
Placebo
n=8 Participants
Single intravenous placebo dose.
|
30 mg LY2928057
n=6 Participants
Day 1: single 30-mg LY2928057 intravenous dose; Days 2 and 3: observation period; Days 4 and 5: single 30-mg LY2928057 intravenous dose followed by 24-hour observation period; Days 6 and 7: single 30-mg LY2928057 intravenous dose; Days 8-85: participant follow-up for minimum of 12 weeks to assess the safety, immunogenicity, and pharmacokinetic profile of 30 mg LY2928057.
|
100 mg LY2928057
n=6 Participants
Day 1: single 100-mg LY2928057 intravenous dose; Days 2 and 3: observation period; Days 4 and 5: single 100-mg LY2928057 intravenous dose followed by 24-hour observation period; Days 6 and 7: single 100-mg LY2928057 intravenous dose; Days 8-85: participant follow-up for minimum of 12 weeks to assess the safety, immunogenicity, and pharmacokinetic profile of 100 mg LY2928057.
|
300 mg LY2928057
n=6 Participants
Day 1: single 300-mg LY2928057 intravenous dose; Days 2 and 3: observation period; Days 4 and 5: 1 participant receives single 300-mg LY2928057 intravenous dose followed by 24-hour observation period; Days 6 and 7: single 300-mg LY2928057 intravenous dose; Days 8-85: participant follow-up for minimum of 12 weeks to assess the safety, immunogenicity, and pharmacokinetic profile of 300 mg LY2928057.
|
1000 mg LY2928057
n=6 Participants
Day 1: single 1000-mg LY2928057 intravenous dose; Days 2 and 3: observation period; Days 4 and 5: single 1000-mg LY2928057 intravenous dose followed by 24-hour observation period; Days 6 and 7: single 1000-mg LY2928057 intravenous dose; Days 8-85: participant follow-up for minimum of 12 weeks to assess the safety, immunogenicity, and pharmacokinetic profile of 1000 mg LY2928057.
|
|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Adverse Effects
|
7 participants
|
6 participants
|
5 participants
|
5 participants
|
6 participants
|
SECONDARY outcome
Timeframe: Predose, end of infusion, 4, 12, and 24 hours post-infusion on Days 3, 5, 8, 11, 15, 22, 29, 43, 50, 57, 64, 71, and 85Population: The analysis population included all randomized participants who received at least 1 dose of LY2928057 and provided samples for pharmacokinetic AUC analyses.
Area under the LY2928057 plasma concentration-time curve extrapolated to infinite time (AUC0-∞).
Outcome measures
| Measure |
Placebo
n=6 Participants
Single intravenous placebo dose.
|
30 mg LY2928057
n=6 Participants
Day 1: single 30-mg LY2928057 intravenous dose; Days 2 and 3: observation period; Days 4 and 5: single 30-mg LY2928057 intravenous dose followed by 24-hour observation period; Days 6 and 7: single 30-mg LY2928057 intravenous dose; Days 8-85: participant follow-up for minimum of 12 weeks to assess the safety, immunogenicity, and pharmacokinetic profile of 30 mg LY2928057.
|
100 mg LY2928057
n=6 Participants
Day 1: single 100-mg LY2928057 intravenous dose; Days 2 and 3: observation period; Days 4 and 5: single 100-mg LY2928057 intravenous dose followed by 24-hour observation period; Days 6 and 7: single 100-mg LY2928057 intravenous dose; Days 8-85: participant follow-up for minimum of 12 weeks to assess the safety, immunogenicity, and pharmacokinetic profile of 100 mg LY2928057.
|
300 mg LY2928057
n=6 Participants
Day 1: single 300-mg LY2928057 intravenous dose; Days 2 and 3: observation period; Days 4 and 5: 1 participant receives single 300-mg LY2928057 intravenous dose followed by 24-hour observation period; Days 6 and 7: single 300-mg LY2928057 intravenous dose; Days 8-85: participant follow-up for minimum of 12 weeks to assess the safety, immunogenicity, and pharmacokinetic profile of 300 mg LY2928057.
|
1000 mg LY2928057
Day 1: single 1000-mg LY2928057 intravenous dose; Days 2 and 3: observation period; Days 4 and 5: single 1000-mg LY2928057 intravenous dose followed by 24-hour observation period; Days 6 and 7: single 1000-mg LY2928057 intravenous dose; Days 8-85: participant follow-up for minimum of 12 weeks to assess the safety, immunogenicity, and pharmacokinetic profile of 1000 mg LY2928057.
|
|---|---|---|---|---|---|
|
Pharmacokinetics, Area Under the Curve (AUC)
|
45500 nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 53
|
1000000 nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 23
|
4060000 nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 40
|
19700000 nanogram*hour per milliliter (ng*h/mL)
Geometric Coefficient of Variation 28
|
—
|
SECONDARY outcome
Timeframe: Predose, end of infusion, 4, 12, and 24 hours post-infusion on Days 3, 5, 8, 11, 15, 22, 29, 43, 50, 57, 64, 71, and 85Population: The analysis population included all randomized participants who received at least 1 dose of LY2928057 and provided samples for pharmacokinetic Cmax analyses.
Outcome measures
| Measure |
Placebo
n=6 Participants
Single intravenous placebo dose.
|
30 mg LY2928057
n=6 Participants
Day 1: single 30-mg LY2928057 intravenous dose; Days 2 and 3: observation period; Days 4 and 5: single 30-mg LY2928057 intravenous dose followed by 24-hour observation period; Days 6 and 7: single 30-mg LY2928057 intravenous dose; Days 8-85: participant follow-up for minimum of 12 weeks to assess the safety, immunogenicity, and pharmacokinetic profile of 30 mg LY2928057.
|
100 mg LY2928057
n=6 Participants
Day 1: single 100-mg LY2928057 intravenous dose; Days 2 and 3: observation period; Days 4 and 5: single 100-mg LY2928057 intravenous dose followed by 24-hour observation period; Days 6 and 7: single 100-mg LY2928057 intravenous dose; Days 8-85: participant follow-up for minimum of 12 weeks to assess the safety, immunogenicity, and pharmacokinetic profile of 100 mg LY2928057.
|
300 mg LY2928057
n=6 Participants
Day 1: single 300-mg LY2928057 intravenous dose; Days 2 and 3: observation period; Days 4 and 5: 1 participant receives single 300-mg LY2928057 intravenous dose followed by 24-hour observation period; Days 6 and 7: single 300-mg LY2928057 intravenous dose; Days 8-85: participant follow-up for minimum of 12 weeks to assess the safety, immunogenicity, and pharmacokinetic profile of 300 mg LY2928057.
|
1000 mg LY2928057
Day 1: single 1000-mg LY2928057 intravenous dose; Days 2 and 3: observation period; Days 4 and 5: single 1000-mg LY2928057 intravenous dose followed by 24-hour observation period; Days 6 and 7: single 1000-mg LY2928057 intravenous dose; Days 8-85: participant follow-up for minimum of 12 weeks to assess the safety, immunogenicity, and pharmacokinetic profile of 1000 mg LY2928057.
|
|---|---|---|---|---|---|
|
Pharmacokinetics, Maximum Concentration (Cmax)
|
4560 ng/mL
Geometric Coefficient of Variation 21
|
27400 ng/mL
Geometric Coefficient of Variation 14
|
88500 ng/mL
Geometric Coefficient of Variation 19
|
276000 ng/mL
Geometric Coefficient of Variation 22
|
—
|
SECONDARY outcome
Timeframe: Predose, end of infusion, 4, 12, and 24 hours post-infusion on Days 3, 5, 8, 11, 15, 22, 29, 43, 50, 57, 64, 71, and 85Population: The analysis population included all randomized participants who received at least 1 dose of LY2928057 and provided samples for pharmacokinetic tmax analyses.
Outcome measures
| Measure |
Placebo
n=6 Participants
Single intravenous placebo dose.
|
30 mg LY2928057
n=6 Participants
Day 1: single 30-mg LY2928057 intravenous dose; Days 2 and 3: observation period; Days 4 and 5: single 30-mg LY2928057 intravenous dose followed by 24-hour observation period; Days 6 and 7: single 30-mg LY2928057 intravenous dose; Days 8-85: participant follow-up for minimum of 12 weeks to assess the safety, immunogenicity, and pharmacokinetic profile of 30 mg LY2928057.
|
100 mg LY2928057
n=6 Participants
Day 1: single 100-mg LY2928057 intravenous dose; Days 2 and 3: observation period; Days 4 and 5: single 100-mg LY2928057 intravenous dose followed by 24-hour observation period; Days 6 and 7: single 100-mg LY2928057 intravenous dose; Days 8-85: participant follow-up for minimum of 12 weeks to assess the safety, immunogenicity, and pharmacokinetic profile of 100 mg LY2928057.
|
300 mg LY2928057
n=6 Participants
Day 1: single 300-mg LY2928057 intravenous dose; Days 2 and 3: observation period; Days 4 and 5: 1 participant receives single 300-mg LY2928057 intravenous dose followed by 24-hour observation period; Days 6 and 7: single 300-mg LY2928057 intravenous dose; Days 8-85: participant follow-up for minimum of 12 weeks to assess the safety, immunogenicity, and pharmacokinetic profile of 300 mg LY2928057.
|
1000 mg LY2928057
Day 1: single 1000-mg LY2928057 intravenous dose; Days 2 and 3: observation period; Days 4 and 5: single 1000-mg LY2928057 intravenous dose followed by 24-hour observation period; Days 6 and 7: single 1000-mg LY2928057 intravenous dose; Days 8-85: participant follow-up for minimum of 12 weeks to assess the safety, immunogenicity, and pharmacokinetic profile of 1000 mg LY2928057.
|
|---|---|---|---|---|---|
|
Pharmacokinetics, Time to Maximum Concentration (Tmax)
|
0.50 hour (h)
Interval 0.5 to 0.5
|
0.50 hour (h)
Interval 0.5 to 0.5
|
0.50 hour (h)
Interval 0.5 to 0.5
|
0.50 hour (h)
Interval 0.5 to 4.0
|
—
|
SECONDARY outcome
Timeframe: Predose, end of infusion, 4, 12, and 24 hours post-infusion on Days 3, 5, 8, 11, 15, 22, 29, 43, 50, 57, 64, 71, and 85Population: The analysis population included all randomized participants who received at least 1 dose of LY2928057 and provided samples for pharmacokinetic systemic CL analyses.
CL=total body clearance of LY2928057 calculated after intravenous administration. Systemic CL was derived from LY2928057 serum concentration data following intravenous administration using classical non compartmental analysis (WinNonlin version 5.3).
Outcome measures
| Measure |
Placebo
n=6 Participants
Single intravenous placebo dose.
|
30 mg LY2928057
n=6 Participants
Day 1: single 30-mg LY2928057 intravenous dose; Days 2 and 3: observation period; Days 4 and 5: single 30-mg LY2928057 intravenous dose followed by 24-hour observation period; Days 6 and 7: single 30-mg LY2928057 intravenous dose; Days 8-85: participant follow-up for minimum of 12 weeks to assess the safety, immunogenicity, and pharmacokinetic profile of 30 mg LY2928057.
|
100 mg LY2928057
n=6 Participants
Day 1: single 100-mg LY2928057 intravenous dose; Days 2 and 3: observation period; Days 4 and 5: single 100-mg LY2928057 intravenous dose followed by 24-hour observation period; Days 6 and 7: single 100-mg LY2928057 intravenous dose; Days 8-85: participant follow-up for minimum of 12 weeks to assess the safety, immunogenicity, and pharmacokinetic profile of 100 mg LY2928057.
|
300 mg LY2928057
n=6 Participants
Day 1: single 300-mg LY2928057 intravenous dose; Days 2 and 3: observation period; Days 4 and 5: 1 participant receives single 300-mg LY2928057 intravenous dose followed by 24-hour observation period; Days 6 and 7: single 300-mg LY2928057 intravenous dose; Days 8-85: participant follow-up for minimum of 12 weeks to assess the safety, immunogenicity, and pharmacokinetic profile of 300 mg LY2928057.
|
1000 mg LY2928057
Day 1: single 1000-mg LY2928057 intravenous dose; Days 2 and 3: observation period; Days 4 and 5: single 1000-mg LY2928057 intravenous dose followed by 24-hour observation period; Days 6 and 7: single 1000-mg LY2928057 intravenous dose; Days 8-85: participant follow-up for minimum of 12 weeks to assess the safety, immunogenicity, and pharmacokinetic profile of 1000 mg LY2928057.
|
|---|---|---|---|---|---|
|
Pharmacokinetics, Systemic Clearance (CL)
|
0.6590 liter per hour (L/h)
Geometric Coefficient of Variation 53
|
0.0999 liter per hour (L/h)
Geometric Coefficient of Variation 23
|
0.0739 liter per hour (L/h)
Geometric Coefficient of Variation 40
|
0.0507 liter per hour (L/h)
Geometric Coefficient of Variation 28
|
—
|
SECONDARY outcome
Timeframe: Predose, end of infusion, 4, 12, and 24 hours post-infusion on Days 3, 5, 8, 11, 15, 22, 29, 43, 50, 57, 64, 71, and 85Population: The analysis population included all randomized participants who received at least 1 dose of LY2928057 and provided samples for pharmacokinetic Vss analyses.
V=LY2928057 steady-state volume of distribution (Vss)
Outcome measures
| Measure |
Placebo
n=6 Participants
Single intravenous placebo dose.
|
30 mg LY2928057
n=6 Participants
Day 1: single 30-mg LY2928057 intravenous dose; Days 2 and 3: observation period; Days 4 and 5: single 30-mg LY2928057 intravenous dose followed by 24-hour observation period; Days 6 and 7: single 30-mg LY2928057 intravenous dose; Days 8-85: participant follow-up for minimum of 12 weeks to assess the safety, immunogenicity, and pharmacokinetic profile of 30 mg LY2928057.
|
100 mg LY2928057
n=6 Participants
Day 1: single 100-mg LY2928057 intravenous dose; Days 2 and 3: observation period; Days 4 and 5: single 100-mg LY2928057 intravenous dose followed by 24-hour observation period; Days 6 and 7: single 100-mg LY2928057 intravenous dose; Days 8-85: participant follow-up for minimum of 12 weeks to assess the safety, immunogenicity, and pharmacokinetic profile of 100 mg LY2928057.
|
300 mg LY2928057
n=6 Participants
Day 1: single 300-mg LY2928057 intravenous dose; Days 2 and 3: observation period; Days 4 and 5: 1 participant receives single 300-mg LY2928057 intravenous dose followed by 24-hour observation period; Days 6 and 7: single 300-mg LY2928057 intravenous dose; Days 8-85: participant follow-up for minimum of 12 weeks to assess the safety, immunogenicity, and pharmacokinetic profile of 300 mg LY2928057.
|
1000 mg LY2928057
Day 1: single 1000-mg LY2928057 intravenous dose; Days 2 and 3: observation period; Days 4 and 5: single 1000-mg LY2928057 intravenous dose followed by 24-hour observation period; Days 6 and 7: single 1000-mg LY2928057 intravenous dose; Days 8-85: participant follow-up for minimum of 12 weeks to assess the safety, immunogenicity, and pharmacokinetic profile of 1000 mg LY2928057.
|
|---|---|---|---|---|---|
|
Pharmacokinetics, Volume of Distribution (V)
|
13.80 L
Geometric Coefficient of Variation 46
|
4.01 L
Geometric Coefficient of Variation 19
|
3.82 L
Geometric Coefficient of Variation 19
|
4.69 L
Geometric Coefficient of Variation 22
|
—
|
SECONDARY outcome
Timeframe: Predose, end of infusion, 4, 12, and 24 hours post-infusion on Days 3, 5, 8, 11, 15, 22, 29, 43, 50, 57, 64, 71, and 85Population: The analysis population included all randomized participants who received at least 1 dose of LY2928057 and provided samples for pharmacokinetic t1/2 analyses.
Outcome measures
| Measure |
Placebo
n=6 Participants
Single intravenous placebo dose.
|
30 mg LY2928057
n=6 Participants
Day 1: single 30-mg LY2928057 intravenous dose; Days 2 and 3: observation period; Days 4 and 5: single 30-mg LY2928057 intravenous dose followed by 24-hour observation period; Days 6 and 7: single 30-mg LY2928057 intravenous dose; Days 8-85: participant follow-up for minimum of 12 weeks to assess the safety, immunogenicity, and pharmacokinetic profile of 30 mg LY2928057.
|
100 mg LY2928057
n=6 Participants
Day 1: single 100-mg LY2928057 intravenous dose; Days 2 and 3: observation period; Days 4 and 5: single 100-mg LY2928057 intravenous dose followed by 24-hour observation period; Days 6 and 7: single 100-mg LY2928057 intravenous dose; Days 8-85: participant follow-up for minimum of 12 weeks to assess the safety, immunogenicity, and pharmacokinetic profile of 100 mg LY2928057.
|
300 mg LY2928057
n=6 Participants
Day 1: single 300-mg LY2928057 intravenous dose; Days 2 and 3: observation period; Days 4 and 5: 1 participant receives single 300-mg LY2928057 intravenous dose followed by 24-hour observation period; Days 6 and 7: single 300-mg LY2928057 intravenous dose; Days 8-85: participant follow-up for minimum of 12 weeks to assess the safety, immunogenicity, and pharmacokinetic profile of 300 mg LY2928057.
|
1000 mg LY2928057
Day 1: single 1000-mg LY2928057 intravenous dose; Days 2 and 3: observation period; Days 4 and 5: single 1000-mg LY2928057 intravenous dose followed by 24-hour observation period; Days 6 and 7: single 1000-mg LY2928057 intravenous dose; Days 8-85: participant follow-up for minimum of 12 weeks to assess the safety, immunogenicity, and pharmacokinetic profile of 1000 mg LY2928057.
|
|---|---|---|---|---|---|
|
Pharmacokinetics, Terminal Half-Life (t1/2)
|
1.2 days
Interval 0.9 to 1.5
|
5.1 days
Interval 3.1 to 7.5
|
6.6 days
Interval 4.7 to 9.2
|
10.3 days
Interval 6.1 to 18.0
|
—
|
SECONDARY outcome
Timeframe: Baseline, end of infusion, 4, 12, and 24 hours post-infusion on Days 3, 5, 8, 11, 15 and 22Population: The analysis population included all randomized participants who received at least 1 dose of LY2928057 and provided plasma data for measuring serum iron levels as the primary pharmacodynamic analysis.
Maximum change from baseline to any point over 22 days post-infusion.
Outcome measures
| Measure |
Placebo
n=8 Participants
Single intravenous placebo dose.
|
30 mg LY2928057
n=6 Participants
Day 1: single 30-mg LY2928057 intravenous dose; Days 2 and 3: observation period; Days 4 and 5: single 30-mg LY2928057 intravenous dose followed by 24-hour observation period; Days 6 and 7: single 30-mg LY2928057 intravenous dose; Days 8-85: participant follow-up for minimum of 12 weeks to assess the safety, immunogenicity, and pharmacokinetic profile of 30 mg LY2928057.
|
100 mg LY2928057
n=6 Participants
Day 1: single 100-mg LY2928057 intravenous dose; Days 2 and 3: observation period; Days 4 and 5: single 100-mg LY2928057 intravenous dose followed by 24-hour observation period; Days 6 and 7: single 100-mg LY2928057 intravenous dose; Days 8-85: participant follow-up for minimum of 12 weeks to assess the safety, immunogenicity, and pharmacokinetic profile of 100 mg LY2928057.
|
300 mg LY2928057
n=6 Participants
Day 1: single 300-mg LY2928057 intravenous dose; Days 2 and 3: observation period; Days 4 and 5: 1 participant receives single 300-mg LY2928057 intravenous dose followed by 24-hour observation period; Days 6 and 7: single 300-mg LY2928057 intravenous dose; Days 8-85: participant follow-up for minimum of 12 weeks to assess the safety, immunogenicity, and pharmacokinetic profile of 300 mg LY2928057.
|
1000 mg LY2928057
n=6 Participants
Day 1: single 1000-mg LY2928057 intravenous dose; Days 2 and 3: observation period; Days 4 and 5: single 1000-mg LY2928057 intravenous dose followed by 24-hour observation period; Days 6 and 7: single 1000-mg LY2928057 intravenous dose; Days 8-85: participant follow-up for minimum of 12 weeks to assess the safety, immunogenicity, and pharmacokinetic profile of 1000 mg LY2928057.
|
|---|---|---|---|---|---|
|
Change From Baseline in Serum Iron
|
32.9 microgram per deciliter (µg/dL)
Standard Deviation 17.5
|
71.9 microgram per deciliter (µg/dL)
Standard Deviation 36.1
|
59.9 microgram per deciliter (µg/dL)
Standard Deviation 22.4
|
95.1 microgram per deciliter (µg/dL)
Standard Deviation 49.8
|
96.3 microgram per deciliter (µg/dL)
Standard Deviation 51.9
|
SECONDARY outcome
Timeframe: Baseline through Day 85Population: The analysis population included all randomized participants who received at least 1 dose of LY2928057 and antibody titer results.
Outcome measures
| Measure |
Placebo
n=8 Participants
Single intravenous placebo dose.
|
30 mg LY2928057
n=6 Participants
Day 1: single 30-mg LY2928057 intravenous dose; Days 2 and 3: observation period; Days 4 and 5: single 30-mg LY2928057 intravenous dose followed by 24-hour observation period; Days 6 and 7: single 30-mg LY2928057 intravenous dose; Days 8-85: participant follow-up for minimum of 12 weeks to assess the safety, immunogenicity, and pharmacokinetic profile of 30 mg LY2928057.
|
100 mg LY2928057
n=6 Participants
Day 1: single 100-mg LY2928057 intravenous dose; Days 2 and 3: observation period; Days 4 and 5: single 100-mg LY2928057 intravenous dose followed by 24-hour observation period; Days 6 and 7: single 100-mg LY2928057 intravenous dose; Days 8-85: participant follow-up for minimum of 12 weeks to assess the safety, immunogenicity, and pharmacokinetic profile of 100 mg LY2928057.
|
300 mg LY2928057
n=6 Participants
Day 1: single 300-mg LY2928057 intravenous dose; Days 2 and 3: observation period; Days 4 and 5: 1 participant receives single 300-mg LY2928057 intravenous dose followed by 24-hour observation period; Days 6 and 7: single 300-mg LY2928057 intravenous dose; Days 8-85: participant follow-up for minimum of 12 weeks to assess the safety, immunogenicity, and pharmacokinetic profile of 300 mg LY2928057.
|
1000 mg LY2928057
n=6 Participants
Day 1: single 1000-mg LY2928057 intravenous dose; Days 2 and 3: observation period; Days 4 and 5: single 1000-mg LY2928057 intravenous dose followed by 24-hour observation period; Days 6 and 7: single 1000-mg LY2928057 intravenous dose; Days 8-85: participant follow-up for minimum of 12 weeks to assess the safety, immunogenicity, and pharmacokinetic profile of 1000 mg LY2928057.
|
|---|---|---|---|---|---|
|
Number of Participants Forming Antibody to LY2928057
|
0 participants
|
3 participants
|
2 participants
|
5 participants
|
4 participants
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
30 mg LY2928057
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
100 mg LY2928057
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
300 mg LY2928057
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
1000 mg LY2928057
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=8 participants at risk
Single intravenous placebo dose.
|
30 mg LY2928057
n=6 participants at risk
Day 1: single 30-mg LY2928057 intravenous dose; Days 2 and 3: observation period; Days 4 and 5: single 30-mg LY2928057 intravenous dose followed by 24-hour observation period; Days 6 and 7: single 30-mg LY2928057 intravenous dose; Days 8-85: participant follow-up for minimum of 12 weeks to assess the safety, immunogenicity, and pharmacokinetic profile of 30 mg LY2928057.
|
100 mg LY2928057
n=6 participants at risk
Day 1: single 100-mg LY2928057 intravenous dose; Days 2 and 3: observation period; Days 4 and 5: single 100-mg LY2928057 intravenous dose followed by 24-hour observation period; Days 6 and 7: single 100-mg LY2928057 intravenous dose; Days 8-85: participant follow-up for minimum of 12 weeks to assess the safety, immunogenicity, and pharmacokinetic profile of 100 mg LY2928057.
|
300 mg LY2928057
n=6 participants at risk
Day 1: single 300-mg LY2928057 intravenous dose; Days 2 and 3: observation period; Days 4 and 5: 1 participant receives single 300-mg LY2928057 intravenous dose followed by 24-hour observation period; Days 6 and 7: single 300-mg LY2928057 intravenous dose; Days 8-85: participant follow-up for minimum of 12 weeks to assess the safety, immunogenicity, and pharmacokinetic profile of 300 mg LY2928057.
|
1000 mg LY2928057
n=6 participants at risk
Day 1: single 1000-mg LY2928057 intravenous dose; Days 2 and 3: observation period; Days 4 and 5: single 1000-mg LY2928057 intravenous dose followed by 24-hour observation period; Days 6 and 7: single 1000-mg LY2928057 intravenous dose; Days 8-85: participant follow-up for minimum of 12 weeks to assess the safety, immunogenicity, and pharmacokinetic profile of 1000 mg LY2928057.
|
|---|---|---|---|---|---|
|
Eye disorders
Conjunctival hyperaemia
|
0.00%
0/8
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Eye disorders
Eye swelling
|
0.00%
0/8
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/8
|
16.7%
1/6 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Gastrointestinal disorders
Mouth ulceration
|
12.5%
1/8 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
General disorders
Application site erythema
|
0.00%
0/8
|
0.00%
0/6
|
33.3%
2/6 • Number of events 3
|
0.00%
0/6
|
0.00%
0/6
|
|
General disorders
Catheter site pain
|
0.00%
0/8
|
66.7%
4/6 • Number of events 4
|
16.7%
1/6 • Number of events 1
|
33.3%
2/6 • Number of events 2
|
0.00%
0/6
|
|
General disorders
Catheter site related reaction
|
12.5%
1/8 • Number of events 2
|
83.3%
5/6 • Number of events 7
|
50.0%
3/6 • Number of events 5
|
33.3%
2/6 • Number of events 4
|
66.7%
4/6 • Number of events 6
|
|
General disorders
Fatigue
|
12.5%
1/8 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
General disorders
Infusion site erythema
|
12.5%
1/8 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
|
General disorders
Infusion site haematoma
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
General disorders
Pain
|
12.5%
1/8 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
General disorders
Pyrexia
|
12.5%
1/8 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
|
General disorders
Vessel puncture site haematoma
|
12.5%
1/8 • Number of events 2
|
16.7%
1/6 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
16.7%
1/6 • Number of events 2
|
16.7%
1/6 • Number of events 1
|
|
General disorders
Vessel puncture site reaction
|
12.5%
1/8 • Number of events 1
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
|
Infections and infestations
Furuncle
|
0.00%
0/8
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Infections and infestations
Influenza
|
0.00%
0/8
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Infections and infestations
Tinea versicolour
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Injury, poisoning and procedural complications
Skin laceration
|
25.0%
2/8 • Number of events 2
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Injury, poisoning and procedural complications
Thermal burn
|
12.5%
1/8 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/8
|
33.3%
2/6 • Number of events 3
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/8
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Nervous system disorders
Dizziness
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Nervous system disorders
Headache
|
25.0%
2/8 • Number of events 2
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/8
|
33.3%
2/6 • Number of events 3
|
33.3%
2/6 • Number of events 4
|
16.7%
1/6 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
12.5%
1/8 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
12.5%
1/8 • Number of events 1
|
33.3%
2/6 • Number of events 2
|
33.3%
2/6 • Number of events 2
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
12.5%
1/8 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
33.3%
2/6 • Number of events 4
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/8
|
16.7%
1/6 • Number of events 1
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/8
|
0.00%
0/6
|
16.7%
1/6 • Number of events 2
|
16.7%
1/6 • Number of events 3
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.00%
0/8
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
16.7%
1/6 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/8
|
16.7%
1/6 • Number of events 2
|
0.00%
0/6
|
0.00%
0/6
|
0.00%
0/6
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place